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1.
Medicine (Baltimore) ; 99(36): e22113, 2020 Sep 04.
Artigo em Inglês | MEDLINE | ID: mdl-32899094

RESUMO

OBJECTIVE: Effective analgesia during delivery can not only decrease pain, but also have a significant function in ensuring the safety of baby and mother. Sufentanil is generally used opioid with ropivacaine in epidural anesthesia in labor pain management; however it can cause some adverse reaction. Dexmedetomidine is an a2-adrenoceptor agonist with high selectivity. It possesses opioid-sparing and analgesic effects and it is suitable for the long-term and short-term intraoperative sedation. The purpose of this present study is to compare the analgesic effect of ropivacaine with dexmedetomidine against ropivacaine with sufentanyl in epidural labor. METHODS: This is a single center, placebo-controlled randomized trial which will be performed from May 2020 to May 2021. It was authorized via the Institutional Review Committee in the first medical center of Chinese PLA General Hospital (S2018-211-0). One hundred sixty full-term protozoa are included in this work. They are randomly divided into four groups (n = 40 per group): the RD1 group (with the epidural administration of 0.125% ropivacaine + dexmedetomidine of 0.5 µg/mL), and the RD2 group (with the epidural administration of 0.08% ropivacaine + dexmedetomidine 0.5 µg/mL), the RS1 group (with the epidural administration of 0.125% ropivacaine + sufentanil of 0.5 µg/mL), as well as RS2 group (with the epidural administration of 0.08% ropivacaine + sufentanil of 0.5 µg/mL). Clinical outcomes are pain score, a modified Bromage scale, the Ramsay Sedation Scale, and adverse reactions during analgesia. All the needed analyses are implemented through utilizing SPSS for Windows Version 20.0. RESULTS: The first table shows the clinical outcomes between these four groups. CONCLUSION: This current work can provide a primary evidence regarding the clinical outcomes of dexmedetomidine versus sufentanil for labor epidural analgesia. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5877).


Assuntos
Analgesia Obstétrica/métodos , Analgésicos/uso terapêutico , Anestésicos Locais/uso terapêutico , Dexmedetomidina/uso terapêutico , Ropivacaina/uso terapêutico , Sufentanil/uso terapêutico , Analgesia Epidural/métodos , Analgésicos/administração & dosagem , Analgésicos/efeitos adversos , Analgésicos não Entorpecentes/uso terapêutico , Analgésicos Opioides/uso terapêutico , Anestésicos Locais/administração & dosagem , Anestésicos Locais/efeitos adversos , Dexmedetomidina/administração & dosagem , Dexmedetomidina/efeitos adversos , Quimioterapia Combinada , Feminino , Humanos , Gravidez , Ropivacaina/administração & dosagem , Ropivacaina/efeitos adversos , Sufentanil/administração & dosagem , Sufentanil/efeitos adversos
3.
Expert Opin Pharmacother ; 21(12): 1407-1418, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32486875

RESUMO

INTRODUCTION: Sufentanil is a selective µ-opioid agonist, used intravenously and intrathecally for moderate to severe acute pain. Sublingual sufentanil nanotablets have been developed; 15 mcg tablet for a patient-controlled analgesia device and 30-mcg tablet for a single-dose device administered by a healthcare professional. Dosing interval is a minimum of 20 min for a 15 mcg tablet and a treatment duration of up to 72 hours. The single 30-mcg nanotablet dosing interval is 1 hour. Mean plasma elimination half-life is 13 hours and bioavailability 47-57% after the first sublingual sufentanil tablet. AREAS COVERED: This review focuses on the effectiveness, safety, and feasibility of sublingual sufentanil 30-mcg single dose suspended by a healthcare professional for the management of moderate to severe acute pain. A few Phase 4 studies concerning the sublingual sufentanil tablet system containing 15-mcg nanotablets are also reviewed. EXPERT OPINION: Sufentanil sublingual 30-mcg nanotablets provide effective pain relief in various acute moderate to severe pain states. The safety profile of sublingual sufentanil 30 mcg is typical to opioids nausea, vomiting, and sedation being the most common ones. Sublingual sufentanil 30-mcg nanotablet has the potential for efficient moderate to severe pain management in supervised healthcare facilities.


Assuntos
Dor Aguda/tratamento farmacológico , Analgésicos Opioides/administração & dosagem , Sistemas de Liberação de Medicamentos/métodos , Manejo da Dor/métodos , Dor Pós-Operatória/tratamento farmacológico , Sufentanil/administração & dosagem , Dor Aguda/sangue , Administração Sublingual , Analgesia Controlada pelo Paciente , Analgésicos Opioides/efeitos adversos , Analgésicos Opioides/uso terapêutico , Disponibilidade Biológica , Duração da Terapia , Feminino , Humanos , Náusea/induzido quimicamente , Medição da Dor , Dor Pós-Operatória/sangue , Sufentanil/efeitos adversos , Sufentanil/uso terapêutico , Comprimidos
4.
Medicine (Baltimore) ; 99(22): e20424, 2020 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-32481441

RESUMO

PURPOSE: To evaluate the 95% effective dose of nalbuphine in patient-controlled intravenous analgesia (PCIA) by the sequential method and compare the analgesia efficacy with the equivalent dose of sufentanil on patients undergoing laparoscopic total hysterectomy. METHODS: In the first part, we defined a successful analgesia as the highest VAS ≤3 in 24 hours postoperatively. On the contrary, a failed analgesia was the highest VAS>3. According to the last patient's outcome, the next patients would be given an increase or decreased dose grade. This process ended up with 9 cross-over points. In the second part, 60 patients undergoing laparoscopic total hysterectomy were selected. They were randomly divided into 2 groups (n = 30 each group): receiving sufentanil 1.78 µg/kg (group S) and nalbuphine 1.78 mg/kg (group N). PCIA pump was given at the end of the operation with 5 mL bonus loading. The total amount of PCIA was 100 mL and programmed to deliver 0.5 mL each time with a lockout interval of 15 minutes and the background infusion amount of 2 mL/h. The VAS score and Ramsay score of were collected after the operation, the number of effective pressing times of PCIA were also recorded. Adverse reactions were documented in detail. RESULTS: The 95% effective dose of nalbuphine in PCIA on patients undergoing laparoscopic total hysterectomy was 1.78 mg/kg. There was no significant difference in VAS between the sufentanil group and the nalbuphine groups (P > .05), but the number of the use of PCIA in the group S was more than that in the group N obviously (P <.05). The group S has a lower ramsay sedation score than group N at every time point. (P <.05). The incidence of nausea and vomiting was not statistically significant differences between two groups in the first 24 hours after colonoscopy (P >  q .05). CONCLUSION: Nalbuphine 1.78 mg/kg in PCIA is recommended for the patients undergoing laparoscopic total hysterectomy. And nalbuphine is a reasonable alternative to sufentanil when used in PCIA.


Assuntos
Analgésicos Opioides/administração & dosagem , Histerectomia , Laparoscopia , Nalbufina/administração & dosagem , Dor Pós-Operatória/tratamento farmacológico , Sufentanil/administração & dosagem , Administração Intravenosa , Analgesia Controlada pelo Paciente , Estudos Cross-Over , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Histerectomia/métodos , Laparoscopia/métodos , Pessoa de Meia-Idade
5.
PLoS One ; 15(5): e0233412, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32453759

RESUMO

BACKGROUND: Postoperative depression is one of the most common mental disorders in patients undergoing cancer surgery and it often delays postoperative recovery. We investigated whether dezocine, an analgesic with inhibitory effect on the serotonin and norepinephrine reuptake, could relieve postoperative depressive symptoms in patients undergoing colorectal cancer surgery. METHODS: This randomized, controlled, single-center, double-blind trial was performed in the Second Affiliated Hospital of the Army Medical University. A total of 120 patients were randomly assigned to receive either sufentanil (1.3 µg/kg) with dezocine (1 mg/kg) (dezocine group; n = 60) or only sufentanil (2.3 µg/kg) (control group; n = 60) for patient-controlled intravenous analgesia after colorectal cancer surgery. The primary outcome was the Beck Depression Inventory score at 2 days after surgery. The secondary outcomes included the Beck Anxiety Inventory, sleep quality, and quality of recovery scores. RESULTS: Compared with those in the control group, patients in the dezocine group had lower depression scores (7.3±3.4 vs. 9.9±3.5, mean difference 2.6, 95% CI: 1.4-3.9; P<0.001) at 2 days after surgery and better night sleep quality at the day of surgery (P = 0.010) and at 1 day after the surgery (P<0.001). No significant difference was found in other outcomes between the two groups. CONCLUSIONS: Intravenous analgesia using dezocine can relieve postoperative depression symptoms and improve sleep quality in patients undergoing colorectal cancer surgery.


Assuntos
Analgésicos Opioides/administração & dosagem , Compostos Bicíclicos Heterocíclicos com Pontes/administração & dosagem , Neoplasias Colorretais/cirurgia , Depressão/prevenção & controle , Procedimentos Cirúrgicos do Sistema Digestório/psicologia , Dor Pós-Operatória/tratamento farmacológico , Sufentanil/administração & dosagem , Tetra-Hidronaftalenos/administração & dosagem , Administração Intravenosa , Idoso , Analgesia Controlada pelo Paciente , Analgésicos Opioides/uso terapêutico , Compostos Bicíclicos Heterocíclicos com Pontes/uso terapêutico , China , Depressão/etiologia , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória/psicologia , Complicações Pós-Operatórias/tratamento farmacológico , Complicações Pós-Operatórias/psicologia , Sufentanil/uso terapêutico , Tetra-Hidronaftalenos/uso terapêutico , Resultado do Tratamento
7.
Eur J Clin Pharmacol ; 76(4): 501-506, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31912188

RESUMO

PURPOSE: To systematically compare the efficacy and safety of sufentanil versus fentanyl for pain relief in labor involving combined spinal-epidural analgesia (CSEA), a systematic review and meta-analysis of randomized controlled trials targeting parturients requesting labor analgesia was conducted. METHODS: The primary outcome measure was visual analog scale scores assessed at 10, 15, 30, and 60 min after intrathecal injection. Secondary outcomes included duration of spinal analgesia, incidence of side effects in parturients, and neonatal Apgar scores. RESULTS: Twelve randomized controlled trials, including data from 881 patients fulfilled the inclusion criteria. No clinically meaningful differences in pain reduction after intrathecal injection were found between the two analgesics. Sufentanil extended the duration of spinal analgesia by 25.40 min (95% CI 21.82 to 28.98 min; p < 0.00001) compared with fentanyl. The risk for pruritus, nausea, and vomiting among parturients was 82% for those using sufentanil (relative risk 0.82 [95% CI 0.67-0.99]; p = 0.04) and 48% for those using fentanyl (relative risk 0.48 [95% CI 0.29-0.80]; p = 0.005). Both the synthesis results and sensitivity analysis demonstrated no differences in the risk for respiratory depression between parturients using sufentanil versus fentanyl. The neonates in sufentanil group exhibited higher Apgar scores than the fentanyl group 5 min after delivery (weighted mean difference 0.10 [95% CI 0.05-0.16]; p = 0.0002). CONCLUSION: Existing evidence suggests that compared with fentanyl, sufentanil used for analgesia in combined spinal-epidural during labor is more effective in extending the duration of spinal analgesia, and may be safer for the infant. There was overall low clinical and statistical heterogeneity among the included studies. For all outcomes, variations caused by heterogeneity across trials were acceptable. Thus the findings of this meta-analysis may provide additional evidence for future clinical practices of pain relief in labor involving CSEA. Stronger evidence supporting this conclusion will require data from more high-quality and multicenter randomized controlled trials.


Assuntos
Analgesia Epidural/métodos , Analgesia Obstétrica/métodos , Analgésicos Opioides/uso terapêutico , Fentanila/uso terapêutico , Trabalho de Parto/efeitos dos fármacos , Dor/tratamento farmacológico , Sufentanil/uso terapêutico , Analgésicos Opioides/administração & dosagem , Índice de Apgar , Feminino , Fentanila/administração & dosagem , Humanos , Recém-Nascido , Injeções Espinhais , Gravidez , Sufentanil/administração & dosagem
8.
Clin Ther ; 42(1): 210-219, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31955968

RESUMO

PURPOSE: Worldwide, there are only few studies focusing on labor analgesia on the MLAC (minimum local analgesic concentration) or EC50 (median effective concentration) of sufentanil and ropivacaine. Therefore, we determine the MLAC or EC50 of sufentanil and ropivacaine for epidural analgesia by using an up-down sequential allocation and survey its adverse effect in a prospective blinded randomized trial. METHODS: Sixty nulliparous full-term parturients who required labor analgesia were recruited and randomly divided into the sufentanil and ropivacaine groups. The formulation was 25 µg sufentanil combined with 0.1% ropivacaine (added 0.9% normal saline to 75 ml). According to the response of a previous parturient, the dosage of sufentanil was increased or decreased by 5 µg in the sufetanil group; meanwhile, we also administrated an initial concentration of 0.1% ropivacaine combined with 22.5 µg sufentanil (added 0.9% normal saline to 75 ml) in the ropivacaine group. The concentration of ropivacaine was increased or decreased by 0.01% following the response of the previous parturient. The Brownlee up-down sequential allocation was used to estimate the MLAC of epidural ropivacaine and its 95% confidence intervals in labor analgesia. FINDINGS: There were no significant changes for the two groups, including for age, height weight, active stage, second stage of labor, and gestational weeks (P = 0.769, 0.900, 0.603, 0.441, 0.577, and 0.695, respectively). The VAS scores of the parturient decreased to varying degrees (P < 0.0001) after labor analgesia compared with VAS before labor analgesia, and the most effective analgesia was reached in 60 min. The EC50 dose of epidural ropivacaine combined with 0.3 µg/mL sufentanil was 0.09687%, and the 95% CI was 0.08944%~0.1043%. Five parturients had PONV, and the incidence rate was 16.7%; one parturient had pruritus, so the incidence rate was 3.3%. The EC50 dose of epidural sulfetanil combined with 0.1% ropivacaine was 18.76 µg with a 95% confidence interval of 13.5-24.48 µg. There were no significant differences in the active stage, second stage of labor, and maternal and fetal hemodynamic data between the two groups. Notably, the Apgar scores for 1 min and 5 min were 10 scores for almost all of these patients. There were no significant differences between the two groups for maternal and fetal side effects, which had very low incidence rates. IMPLICATIONS: The MLAC of epidural sufentanil or ropivacaine could provide satisfactory and safe analgesia for parturients while having a low incidence rate of side effects.


Assuntos
Analgesia Epidural , Analgesia Obstétrica , Analgésicos Opioides/administração & dosagem , Anestésicos Locais/administração & dosagem , Ropivacaina/administração & dosagem , Sufentanil/administração & dosagem , Adulto , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Humanos , Trabalho de Parto , Gravidez
9.
Pediatr Neurosurg ; 55(1): 36-41, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31940654

RESUMO

INTRODUCTION: Intravenous patient-controlled analgesia (PCA) has been one of the most popular modalities for postoperative pain management in orthopedic surgery, plastic surgery, or neurosurgery in children. OBJECTIVE: We compared the effects of fentanyl and sufentanil used in intravenous PCA on postoperative pain management and opioid-related side effects in pediatric moyamoya disease. METHODS: This retrospective study included 97 pediatric patients who underwent surgery for moyamoya disease. Preoperative and perioperative parameters were assessed. The PCA regimen was as follows: fentanyl group (0.2 µg/kg/mL, 1 mL of loading volume, 0.1 µg/kg/h of basal infusion, a bolus of 0.2 µg/kg on demand, "lock-out" interval of 15 min); sufen-tanil group (0.04 µg/kg/mL, 1 mL of loading volume, 0.02 µg/kg/h of basal infusion, a bolus of 0.04 µg/kg on demand, 15 min lock-out), 10 µg/kg (up to 300 µg) of ramosetron for prophylaxis of postoperative nausea and vomiting with the same loading dose in both groups. Peripheral nerve blocks were performed. Pain was assessed by numeric rating scale or revised Faces Pain Scale. Side effects were reviewed. RESULTS: The two groups showed similar pain scores and incidence of nausea or vomiting during the first 48 h postoperatively. Additional analgesics were more frequent in the fentanyl group, and PCA was discontinued more frequently in the sufentanil group. CONCLUSIONS: Postoperatively, sufen-tanil in PCA provided more analgesia than fentanyl with less additional analgesics in moyamoya disease. However, PCA with sufentanil was more frequently discontinued due to nausea or vomiting compared to fentanyl-based PCA.


Assuntos
Analgesia Controlada pelo Paciente , Analgésicos Opioides/uso terapêutico , Fentanila/uso terapêutico , Doença de Moyamoya/cirurgia , Dor Pós-Operatória/tratamento farmacológico , Sufentanil/uso terapêutico , Administração Intravenosa , Adolescente , Analgésicos Opioides/efeitos adversos , Criança , Pré-Escolar , Feminino , Fentanila/administração & dosagem , Fentanila/efeitos adversos , Humanos , Masculino , Náusea/etiologia , Medição da Dor , Estudos Retrospectivos , Sufentanil/administração & dosagem , Sufentanil/efeitos adversos , Vômito/etiologia
10.
J Med Case Rep ; 14(1): 1, 2020 Jan 03.
Artigo em Inglês | MEDLINE | ID: mdl-31900197

RESUMO

BACKGROUND: Sufentanil is a potent opioid uncommonly used to manage pain and is rarely administered via an intrathecal pain pump system. CASE PRESENTATION: This case illustrates the use of intrathecal sufentanil in a 50-year-old Caucasian man for the management of chronic pain; however, the intrathecal drug delivery system experienced a malfunction which led to 1/100th output of the correct dosage. Interesting aspects of this case report include the uncommon choice of sufentanil use for an intrathecal drug delivery system, as well as the unusual pharmacokinetics of this drug. Specifically, this patient did not experience the major withdrawal that would be expected given significant under dosing of opioid, and this may be explained by the lipophilicity and context-sensitive half-times of sufentanil. CONCLUSIONS: Because of the absence of a clinically significant withdrawal in this case report, clinicians must be aware of relevant pharmacokinetic properties and unusual intrathecal drug delivery system technologies that influence a patient's response when device malfunction occurs.


Assuntos
Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/farmacocinética , Falha de Equipamento , Sufentanil/administração & dosagem , Sufentanil/farmacocinética , Sistemas de Liberação de Medicamentos/instrumentação , Humanos , Injeções Espinhais/instrumentação , Masculino , Pessoa de Meia-Idade , Medição da Dor
11.
Physiol Res ; 69(1): 157-164, 2020 02 19.
Artigo em Inglês | MEDLINE | ID: mdl-31852207

RESUMO

We aimed to evaluate the regulatory effects of propofol on high-dose remifentanil-induced hyperalgesia. A total of 180 patients receiving laparoscopic cholecystectomy were randomly divided into sevoflurane + high-dose remifentanil (SH) group, sevoflurane + low-dose remifentanil (SL) group and propofol + high-dose remifentanil group (PH) group (n=60). After intravenous administration of midazolam, SH and SL groups were induced with sevoflurane and remifentanil, and PH group was induced with propofol and remifentanil. During anesthesia maintenance, SH and SL groups were given 0.3 microg/kg/min and 0.1 microg/kg/min sevoflurane and remifentanil respectively, and PH group was given 0.3 microg/kg/min propofol and remifentanil. The three groups had significantly different awakening time, extubation time and total dose of remifentanil (P<0.001). Compared with SL group, periumbilical mechanical pain thresholds 6 h and 24 h after surgery significantly decreased in SH group (P<0.05), and the visual analog scale (VAS) scores significantly increased 30 min, 2 h and 6 h after surgery (P<0.05). Compared with SH group, periumbilical mechanical thresholds 6 h and 24 h after surgery were significantly higher in PH group (P<0.05), and VAS scores 30 min, 2 h and 6 h after surgery were significantly lower (P<0.05). PH group first used patient-controlled intravenous analgesia pump significantly later than SL group did (P<0.05). The total consumptions of sufentanil in PH and SL groups were significantly lower than that of SH group (P<0.05). The incidence rates of bradycardia and postoperative chill in PH and SH groups were significantly higher than those of SL group (P<0.05). Anesthesia by infusion of high-dose remifentanil plus sevoflurane caused postoperative hyperalgesia which was relieved through intravenous anesthesia with propofol.


Assuntos
Analgésicos Opioides/efeitos adversos , Anestésicos Intravenosos/farmacologia , Hiperalgesia/induzido quimicamente , Propofol/farmacologia , Remifentanil/efeitos adversos , Adulto , Analgésicos Opioides/administração & dosagem , Anestésicos Inalatórios/farmacologia , Colecistectomia Laparoscópica/efeitos adversos , Humanos , Hiperalgesia/prevenção & controle , Pessoa de Meia-Idade , Dor Pós-Operatória/prevenção & controle , Remifentanil/administração & dosagem , Sevoflurano/farmacologia , Sufentanil/administração & dosagem
12.
Drugs R D ; 20(1): 1-10, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31820365

RESUMO

BACKGROUND: The application of modeling and simulation approaches in clinical pharmacology studies has gained momentum over the last 20 years. OBJECTIVES: The objective of this study was to develop six empirical models from clearance data obtained from children aged > 2 years and adults to evaluate the suitability of the models to predict drug clearance in children aged ≤ 2 years (preterm, term, and infants). METHODS: Ten drugs were included in this study and administered intravenously: alfentanil, amikacin, busulfan, cefetamet, meperidine, oxycodone, propofol, sufentanil, theophylline, and tobramycin. These drugs were selected according to the availability of individual subjects' weight, age, and clearance data (concentration-time data for these drugs were not available to the author). The chosen drugs are eliminated by extensive metabolism by either the renal route or both the renal and hepatic routes. The six empirical models were (1) age and body weight-dependent sigmoidal maximum possible effect (Emax) maturation model, (2) body weight-dependent sigmoidal Emax model, (3) uridine 5'-diphospho [body weight-dependent allometric exponent model (BDE)], (4) age-dependent allometric exponent model (ADE), (5) a semi-physiological model, and (6) an allometric model developed from children aged > 2 years to adults. The model-predicted clearance values were compared with observed clearance values in an individual child. In this analysis, a prediction error of ≤ 50% for mean or individual clearance values was considered acceptable. RESULTS: Across all age groups and the ten drugs, data for 282 children were compared between observed and model-predicted clearance values. The validation data consisted of 33 observations (sum of different age groups for ten drugs). Only three of the six models (body weight-dependent sigmoidal Emax model, ADE, and semi-physiological model) provided reasonably accurate predictions of clearance (> 80% observation with ≤ 50% prediction error) in children aged ≤ 2 years. In most instances, individual predicted clearance values were erratic (as indicated by % error) and were not in agreement with the observed clearance values. CONCLUSIONS: The study indicated that simple empirical models can provide more accurate results than complex empirical models.


Assuntos
Taxa de Depuração Metabólica , Modelos Biológicos , Adulto , Alfentanil/administração & dosagem , Alfentanil/metabolismo , Amicacina/administração & dosagem , Amicacina/metabolismo , Bussulfano/administração & dosagem , Bussulfano/metabolismo , Ceftizoxima/administração & dosagem , Ceftizoxima/análogos & derivados , Ceftizoxima/metabolismo , Pré-Escolar , Humanos , Lactente , Injeções Intravenosas , Meperidina/administração & dosagem , Meperidina/metabolismo , Oxicodona/administração & dosagem , Oxicodona/metabolismo , Propofol/administração & dosagem , Propofol/metabolismo , Sufentanil/administração & dosagem , Sufentanil/metabolismo , Teofilina/administração & dosagem , Teofilina/metabolismo , Tobramicina/administração & dosagem , Tobramicina/metabolismo
13.
Curr Med Res Opin ; 36(2): 277-284, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-31612723

RESUMO

Objective: To evaluate the real-life effectiveness, safety, tolerability and patient-reported outcomes (PRO) of the sufentanil sublingual tablet system (SSTS) for postoperative pain management (POPM).Methods: This prospective, multicenter, noninterventional, study included adults with acute moderate to severe postoperative pain who self-administered sufentanil using the SSTS. Main outcome measures were pain intensity at rest (numerical rating scale [NRS]: 0 [no pain] to 10 [most intense pain imaginable]); most intense pain intensity (0-10); 4-point patient assessment of the pain control method ("excellent", "good", "fair", "poor"); patient satisfaction with the pain control level and the method of administration of pain medication (6-point scale: "extremely satisfied", "very satisfied", "satisfied", "dissatisfied", "very dissatisfied", "extremely dissatisfied"). Adverse drug reactions were recorded.Results: The SSTS reduced resting pain intensity in patients (n = 341) from a mean ± SD NRS score of 5.2 ± 2.3 (at SSTS handover) to 1.8 ± 1.6 (3rd day after handover). The proportion of patients with severe pain (for the PRO measure "most intense pain") decreased steadily during the 72 hours of treatment. Overall, 87.1% of the patients reported the method of pain control to be "good" or "excellent"; 91.8% reported being "extremely/very satisfied" or "satisfied" with the level of pain control; and 95.9% were at least satisfied with the method of pain medication administration. SSTS safety and tolerability was typical for opioids and as described in the SSTS Summary of Product Characteristics.Conclusions: The SSTS is a valuable option for real-life POPM and is effective in a wide range of surgical procedures.


Assuntos
Dor Aguda/tratamento farmacológico , Analgesia Controlada pelo Paciente , Analgésicos Opioides/administração & dosagem , Dor Pós-Operatória/tratamento farmacológico , Sufentanil/administração & dosagem , Administração Sublingual , Adulto , Idoso , Analgésicos Opioides/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Comprimidos/uso terapêutico
14.
Anesth Analg ; 130(5): 1264-1273, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-31517677

RESUMO

BACKGROUND: This pilot study investigated the effect of sufentanil titration by 3 different analgesia monitoring devices or clinical signs during general anesthesia. METHODS: Forty-eight patients undergoing radical retropubic prostatectomy with sevoflurane/sufentanil anesthesia were randomly assigned into 4 groups and received sufentanil guided either by 1 of 3 analgesia monitoring devices (Surgical Pleth Index [SPI], Pupillary Pain Index [PPI], Nociception Level [NoL]) or by clinical judgment (control). The primary end point was intraoperative sufentanil consumption. Adrenocorticotropic hormone (ACTH) and cortisol were measured at 4 time points during the day of surgery. Data were analyzed by Kruskal-Wallis and Mann-Whitney U tests and by mixed model and area under the curve (AUC) analyses for group comparisons and time effects of stress hormones. RESULTS: The total amount of sufentanil administration (µg·kg·minute·10) differed between the groups (median [quartiles]: control = 5.6 [4.4-6.4], SPI = 7.2 [4.8-8.4], PPI = 2.0 [1.8-2.9], NoL = 3.8 [3.3-5.1]; PPI versus SPI, -5.1 [-6.6 to -1.3], P < .001; NoL versus SPI, -3.0 [-5.2 to 0.2], P = .024; control versus SPI, -1.6 [-3.7 to 1.7], P = .128; NoL versus PPI, 1.7 [0.6-3.4], P < .001; control versus PPI, 3.4 [2.0-4.6], P < .001; control versus NoL, 1.6 [-0.2 to 3.3], P = .017) (Hodges-Lehmann estimator [99% confidence interval {CI}], P values). The AUC analysis indicated differences among groups in cumulative ACTH levels (ng·liter·minute, natural logarithm (ln)-transformed data) of NoL versus PPI (-1.079 [-1.950 to -0.208], P = .001) and PPI versus SPI (1.192 [0.317-2.068], P= .001), as well as differences in cortisol levels (µg·liter·minute) for PPI versus SPI (46,710 [21,145-72,274], P < .001), NoL versus SPI (27,645 [3163-52,126], P = .003), and control versus SPI (31,824 [6974-56,675], P = .001) (differences in means [99% CI], P value). Secondary end points (postoperative recovery, pain level, and analgesia medication) showed no differences. CONCLUSIONS: The type of analgesia nociception monitoring affected the total amount of sufentanil administered. Lower sufentanil doses in the PPI group were associated with an increased endocrine stress response. Titration by SPI caused no opioid reduction compared to the control but was associated with a reduced endocrine stress response.


Assuntos
Hormônio Adrenocorticotrópico/sangue , Analgésicos Opioides/administração & dosagem , Anestesia Geral/métodos , Monitorização Intraoperatória/métodos , Medição da Dor/métodos , Sufentanil/administração & dosagem , Idoso , Hormônios/sangue , Humanos , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória , Projetos Piloto , Estudos Prospectivos , Prostatectomia/efeitos adversos , Prostatectomia/tendências , Método Simples-Cego , Estresse Psicológico/sangue , Estresse Psicológico/diagnóstico
15.
J Clin Pharm Ther ; 45(1): 59-64, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31660644

RESUMO

WHAT IS KNOWN AND OBJECTIVES: The agreement between prescribed sedation objectives and sedation pump syringe rate adaptation is not optimal. Delays in adjustment of sedation doses are associated with an increased patient length of stay in the intensive care unit. Our objectives were to assess compliance with the approved sedation protocol and to evaluate the impact of a clinical pharmacist daily controlling sedation and analgesia scores and pump syringe rates on patients' outcomes in a critical care unit. METHODS: Prospective before/after study involving 60 adult patients divided into two groups (non-intervention and intervention groups) who received mechanical ventilation and continuous infusions of sedative and analgesic drugs in an intensive care unit. In both groups, data were collected daily in 30 mechanically ventilated patients receiving a sedation/analgesia regimen during a 3-month period according to a standardized protocol. A pharmacist was in charge of intervening with physicians when the local sedation analgesia protocol was not followed. RESULTS AND DISCUSSION: There were no significant differences between the groups in terms of demographic characteristics except a higher proportion of men in the intervention group (70% vs 40%, P = .019). In the control group, sedation and analgesia objectives were not prescribed in more than half the cases. Pharmacist intervention reduced sedation duration (5 [2-11] vs 2 [1-5.5] days, P = .019). The cumulative delay in adaptation of the sedation analgesia electric syringe pump was significantly decreased in the intervention group (8 [0-29.5] vs 28.5 hours [11.1-68.4], P = .034). Total doses of sedatives (midazolam, propofol) and analgesics (sufentanil, remifentanil) per patient were decreased in the intervention group compared to the control group (respectively, P = .24, P = .0009, P = .0013 and P = .0007). CONCLUSIONS: Pharmacist intervention can decrease the sedation duration and the total dose of sedation medications and reinforce adherence to sedation/analgesia guidelines.


Assuntos
Analgésicos/administração & dosagem , Hipnóticos e Sedativos/administração & dosagem , Unidades de Terapia Intensiva , Farmacêuticos/organização & administração , Adulto , Idoso , Estudos Controlados Antes e Depois , Feminino , Fidelidade a Diretrizes , Humanos , Tempo de Internação , Masculino , Midazolam/administração & dosagem , Pessoa de Meia-Idade , Serviço de Farmácia Hospitalar/organização & administração , Guias de Prática Clínica como Assunto , Papel Profissional , Propofol/administração & dosagem , Estudos Prospectivos , Remifentanil/administração & dosagem , Respiração Artificial/métodos , Sufentanil/administração & dosagem
16.
BMC Anesthesiol ; 19(1): 236, 2019 12 19.
Artigo em Inglês | MEDLINE | ID: mdl-31856760

RESUMO

BACKGROUND: Perioperative immune function plays an important role in the prognosis of patients. Several studies have indicated that low-dose opioid receptor blockers can improve immune function. METHODS: Sixty-nine patients undergoing video-assisted thoracoscopic resection of the lung cancer were randomly assigned to either the naloxone group (n = 35) or the non-naloxone group (n = 34) for postoperative analgesia during the first 48 h after the operation. Both groups received sufentanil and palonosetron via postoperative analgesia pump, while 0.05 µg·kg- 1·h- 1 naloxone was added in naloxone group. The primary outcomes were the level of opioid growth factor (OGF) and immune function assessed by natural killer cells and CD4+/CD8+ T-cell ratio. Second outcomes were assessed by the intensity of postoperative pain, postoperative rescue analgesia dose, postoperative nausea and vomiting (PONV). RESULTS: The level of OGF in the naloxone group increased significantly at 24 h (p<0.001) and 48 h after the operation (P < 0.01). The natural killer cells (P < 0.05) and CD4+/CD8+ T-cell ratio (P < 0.01) in the naloxone group increased significantly at 48 h after the operation. The rest VAS scores were better with naloxone at 12 and 24 h after operation(P < 0.05), and the coughing VAS scores were better with naloxone at 48 h after the operation(P < 0.05). The consumption of postoperative rescue analgesics in the naloxone group was lower (0.00(0.00-0.00) vs 25.00(0.00-62.50)), P < 0.05). Postoperative nausea scores at 24 h after operation decreased in naloxone group(0.00 (0.00-0.00) vs 1.00 (0.00-2.00), P < 0.01). CONCLUSION: Infusion of 0.05 µg·kg- 1·h- 1 naloxone for patients undergoing sufentanil-controlled analgesia for postoperative pain can significantly increase the level of OGF, natural killer cells, and CD4+/CD8+ T-cell ratio compared with non-naloxone group, and postoperative pain intensity, request for rescue analgesics, and opioid-related side effects can also be reduced. TRIAL REGISTRATION: The trial was registered at the Chinese Clinical Trial Registry on January 26, 2019 (ChiCTR1900021043).


Assuntos
Neoplasias Pulmonares/cirurgia , Naloxona/administração & dosagem , Sufentanil/administração & dosagem , Cirurgia Torácica Vídeoassistida/métodos , Analgesia Controlada pelo Paciente/métodos , Analgésicos Opioides/administração & dosagem , Relação CD4-CD8 , Feminino , Humanos , Sistema Imunitário/efeitos dos fármacos , Células Matadoras Naturais/imunologia , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória/tratamento farmacológico , Projetos Piloto , Náusea e Vômito Pós-Operatórios/epidemiologia
17.
Medicine (Baltimore) ; 98(52): e18448, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31876726

RESUMO

BACKGROUND: This study aimed to compare the quadratus lumborum block (QLB) method with transversus abdominis plane block (TAPB) for postoperative pain management in patients undergoing laparoscopic colorectal surgery. METHODS: Seventy-four patients scheduled for laparoscopic colorectal surgery were randomly assigned into 2 groups. After surgery, patients received bilateral ultrasound-guided single-dose of QLB or TAPB. Each side was administered with 20 ml of 0.375% ropivacaine. All patients received sufentanil as patient-controlled intravenous analgesia (PCIA). Resting and moving numeric rating scale (NRS) were assessed at 2, 4, 6, 24, 48 hours postoperatively. The primary outcome measure was sufentanil consumption at predetermined time intervals after surgery. RESULTS: Patients in the QLB group used significantly less sufentanil than TAPB group at 24 and 48 hours (P < .05), but not at 6 hours (P = .33) after laparoscopic colorectal surgery. No significant differences in NRS results were found between the two groups at rest or during movement (P > .05). Incidence of dizziness in the QLB group was lower than in TAPB group (P < .05). CONCLUSIONS: The QLB is a more effective postoperative analgesia as it reduces sufentanil consumption compared to TAPB in patients undergoing laparoscopic colorectal surgery.


Assuntos
Músculos Abdominais/inervação , Músculos Abdominais Oblíquos/inervação , Cirurgia Colorretal/métodos , Laparoscopia/métodos , Bloqueio Nervoso/métodos , Dor Pós-Operatória/terapia , Anestésicos Locais/administração & dosagem , Neoplasias Colorretais/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Manejo da Dor/métodos , Ropivacaina/administração & dosagem , Sufentanil/administração & dosagem , Ultrassonografia de Intervenção
18.
Arch Gynecol Obstet ; 300(6): 1551-1557, 2019 12.
Artigo em Inglês | MEDLINE | ID: mdl-31667606

RESUMO

PURPOSE: To evaluate whether programmed intermittent epidural bolus (PIEB) reduces the incidence of maternal intra-partum fever compared with continuous epidural infusion (CEI) during labor. METHODS: Parturients were randomized to receive CEI (CEI group) or PIEB (PIEB group) with 10 ml per hour for epidural labor analgesia with 1500 subjects in each group. The maintaining dose of two groups is 0.08% ropivacaine with 0.4 µg/ml sufentanil, with patient-controlled epidural analgesia (PCEA) dose of 5 ml and lockout interval of 30 min. The incidence of maternal fever, pain score, epidural sensory levels, the number and proportion of PCEA demand, anesthetics consumption, satisfaction score, neonatal Apgar scale, and maternal and neonatal side effects were recorded. RESULTS: It was significantly lower of the incidence of maternal fever beginning at 4 h post-analgesia and continuing until delivery in the PIEB group than the CEI group (4 h: 2.6% vs. 4.2%; 5 h: 7.3% vs. 10.2%; delivery: 5.6% vs. 7.9%; 1 h post-delivery: 3.9% vs. 6.2%; 2 h post-delivery: 2.1 vs. 3.5%; total: 5.8% vs. 8.4% in PIEB and CEI, respectively). Compared with CEI group, pain scores at 3, 4, 5 h post-analgesia and delivery (3 h: 2 [1, 2] vs. 2 [1-3]; 4 h: 2 [2, 3] vs. 3 [2-4]; 5 h: 2 [2, 3] vs. 3 [2-4]; delivery: 3 [2-4] vs. 4 [3, 4] in PIEB and CEI, respectively), the number and proportion of PCEA demand (number: 0.7 ± 0.9 vs. 2.2 ± 1.9; proportion: 42.0% vs. 80.3% in PIEB and CEI, respectively), and anesthetics consumption significantly decreased in the PIEB group (Ropivacaine: 60 ± 13 mg vs. 76 ± 17 mg; Sufentanil: 26 ± 4 mg vs. 32 ± 6 mg in PIEB and CEI, respectively), without severe maternal and neonatal side effects and any difference in neonatal Apgar scale. The epidural sensory levels 2 h post-analgesia (2 h: 8[8, 9] vs. 9[8, 9] in PIEB and CEI) and satisfaction score (9 [9, 10] vs. 7 [6, 7] in PIEB and CEI) were significantly higher in the PIEB group compared with those in the CEI group. CONCLUSIONS: PIEB with 10 ml of 0.08% ropivacaine and 0.4 µg/ml sufentanil hourly provided a lower incidence of intra-partum fever with a better analgesic effect compared with CEI, without any severe maternal and neonatal adverse reactions.


Assuntos
Analgesia Epidural/métodos , Analgesia Obstétrica/métodos , Analgésicos/administração & dosagem , Anestésicos Locais/administração & dosagem , Febre/epidemiologia , Adulto , Analgesia Epidural/efeitos adversos , Analgesia Obstétrica/efeitos adversos , Método Duplo-Cego , Feminino , Febre/prevenção & controle , Humanos , Incidência , Trabalho de Parto , Paridade , Gravidez , Ropivacaina/administração & dosagem , Sufentanil/administração & dosagem
19.
Int J Med Sci ; 16(11): 1439-1446, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31673234

RESUMO

Background: Fentanyl is one of the most widely used opioids for intravenous patient-controlled analgesia (IV-PCA). Sufentanil, a fentanyl analog, is suitable for postoperative pain control because it has no active metabolites and shows a higher therapeutic index and lower frequency of respiratory suppression than fentanyl. This study aimed to compare the two opioids for postoperative pain relief on the basis of analgesic efficacy, adverse effects, and patient satisfaction. Methods: Sixty-four patients undergoing total laparoscopic hysterectomy were randomly allocated into a fentanyl group (n = 31) or a sufentanil group (n = 33). The patients received 50-µg fentanyl or 10-µg sufentanil before induction of anesthesia and 5 minutes after uterine incision during surgery in the fentanyl and sufentanil group, respectively. After arriving at the post-anesthesia care unit (PACU), verbal pain score (VPS) and sedation score were assessed. IV-PCA (fentanyl 1250 µg or sufentanil 250 µg with ondansetron 8 mg; total volume, 60 ml) was connected and continued for 48 h postoperatively. Postoperative pain was evaluated by using the numeric rating scale (NRS; at rest/during cough) at 6, 12, 24, 36, and 48 hours after surgery. The cumulative PCA consumption, patient satisfaction scores, and adverse effects were measured. Results: In the PACU, VPS was significantly higher and rescue fentanyl consumption was higher in the fentanyl group than in the sufentanil group, while the sedation score and adverse effects were comparable between the groups. No significant differences were observed in the NRS scores for pain (at rest/during cough) in the ward over 48 hours postoperatively, but the cumulative PCA consumption was significantly higher in the fentanyl group (47.4 ± 9.9 ml vs. 36.2 ± 14.6 ml, P = 0.01). There were no significant intergroup differences in patient satisfaction score and the incidence of adverse effects in the ward, except for a higher incidence of dry mouth in the fentanyl group. Conclusions: In comparison with fentanyl, sufentanil showed comparable analgesic efficacy and safety with less analgesic consumption (under a potency ratio of 1:5) in IV-PCA after total laparoscopic hysterectomy. Therefore, we suggest that sufentanil can be a useful alternative to fentanyl for IV-PCA.


Assuntos
Analgesia Controlada pelo Paciente/métodos , Fentanila/administração & dosagem , Dor Pós-Operatória/tratamento farmacológico , Sufentanil/administração & dosagem , Administração Intravenosa , Analgésicos Opioides/administração & dosagem , Método Duplo-Cego , Feminino , Humanos , Histerectomia/efeitos adversos , Laparoscopia , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória/fisiopatologia
20.
Physiol Res ; 68(Suppl 1): S59-S64, 2019 11 22.
Artigo em Inglês | MEDLINE | ID: mdl-31755291

RESUMO

The aim of this study was to evaluate the association between OPRM1 and ABCB1 polymorphisms on pain relief with epidural sufentanil in 69 patients after rectosigma resection for cancer. The median number of injections (SD) 2.31 (1.36), IQR=1, required by 118AA subjects was significantly lower in comparison with 118AG group 5.25 (3.13), IQR=6.5, (chi(2)=9.75, p=0.001); correspondingly median drug consumption of 1.16 (0.79), IQR=1.083, defined daily doses (DDD) was significantly less in the 118AA group in comparison with 2.14 (1.17), IQR=2.23, DDD in 118AG subjects, (chi(2)=7.00, p=0.008). Opioid-induced adverse effects were observed in 15 % and 33 % of patients in 118AA and 118AG groups, respectively (chi(2)=8.16, p=0.004). The median number of injections (SD) required by women and men was 3.30 (2.16), IQR=2, and 2.80 (1.59), IQR=1, respectively (chi(2)=6.25, p=0.012). Opioid-induced adverse effects were observed in 26 % and 12 % of women and men, respectively (chi(2)=5.49, p=0.011). Heterozygotes of OPRM1 polymorphism and women were more difficult to treat subpopulations that required higher doses of rescue analgesic medication and suffered more adverse effects.


Assuntos
Analgesia Epidural/métodos , Manejo da Dor/métodos , Polimorfismo Genético/fisiologia , Receptores Opioides mu/genética , Sufentanil/administração & dosagem , Subfamília B de Transportador de Cassetes de Ligação de ATP/genética , Idoso , Idoso de 80 Anos ou mais , Analgésicos Opioides/administração & dosagem , Neoplasias Colorretais/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória/tratamento farmacológico , Estudos Prospectivos
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