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1.
Anesth Analg ; 2021 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-33617181

RESUMO

BACKGROUND: Epidural block are often used for analgesia after open nephrectomy surgery. Subcostal anterior quadratus lumborum block may be an alternative. We therefore tested the hypothesis that the continuous subcostal anterior quadratus lumborum block is noninferior to epidural block for analgesia in patients having open partial nephrectomies. METHODS: Adults having open partial nephrectomies were randomly allocated to epidural or unilateral subcostal anterior quadratus lumborum block. The joint primary outcomes were opioid consumption measured in morphine equivalents and pain measured on a numeric rating scale (0-10) from postanesthesia care unit (PACU) until 72 hours after surgery. The noninferiority deltas were 30% for opioid consumption and 1 point on a 0-10 scale for pain. Secondary outcomes included patient global assessment of pain management on the third postoperative day, the number of antiemetic medication doses through the third postoperative day, duration of PACU stay, and postoperative duration of hospitalization. RESULTS: Twenty-six patients were randomized to anterior quadratus lumborum block and 29 to epidural analgesia. Neither pain scores nor opioid consumption in the quadratus lumborum patients were noninferior to epidural analgesia. At 72 hours, mean ± standard deviation pain scores in subcoastal anterior quadratus lumborum block and epidural group were 4.7 ± 1.8 and 4.1 ± 1.7, with an estimated difference in pain scores of 0.62 (95% confidence interval [CI], 0.74-1.99; noninferiority P = .21). The median [Q1, Q3] opioid consumption was more than doubled in quadratus lumborum patients at 70 mg [43, 125] versus 30 mg [18, 75] in the epidural group with an estimated ratio of geometric means of 1.69 (95% CI, 0.66-4.33; noninferiority P = .80). Patient global assessment and duration of PACU and hospital stays did not differ significantly in the 2 groups. CONCLUSIONS: We were unable to show that subcostal anterior quadratus lumborum block are noninferior to epidural analgesia in terms of pain scores and opioid consumption for open partial nephrectomies. Effectiveness of novel blocks should be rigorously tested in specific surgical setting before widespread adoption.

2.
Anesth Analg ; 132(3): 866-877, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33433116

RESUMO

BACKGROUND: Anesthesiologists typically care for patients having a broad range of procedures. Outcomes might be improved when care is provided by caregivers experienced in particular types of surgery. We tested the hypothesis that intraoperative care provided by pairs of anesthesia caregivers having significant experience with a particular type of surgery reduces a composite of in-hospital death and 6 serious complications, including bleeding, cardiac, gastrointestinal, infectious, respiratory, and urinary complications, compared to care provided by pairs of anesthesia caregivers with less experience. METHODS: We included patients having surgery lasting at least 30 minutes. Using cluster analysis, attending anesthesiologists, and Certified Registered Nurse Anesthetists (CRNAs) were identified as experienced or inexperienced caregivers for each type of surgery at the case level. We then compared surgeries for which anesthesia was provided by a pair of experienced caregivers versus a pair of inexperienced caregivers on our composite outcome. We estimated the average relative effect (ie, the exponentiated average log odds ratio) of receiving anesthesia from an experienced versus inexperienced caregiver pair across the 7 components of the composite outcome using a generalized estimating equation (GEE) model to adjust for between-component correlation and with inverse propensity score weighing to adjust for potential confounding from a host of variables. RESULTS: A total of 8968 patients who received anesthesia care by an experienced pair were compared with 25,361 patients who received care from an inexperienced pair, adjusting for potential confounding. The incidence of composite complications (ie, any component event) was 7.6% (677/8968) for experienced pairs and 12% (2976/25,361) for inexperienced pairs (P < .001). Care by experienced pairs of caregivers was associated with lower odds of the composite outcome with an estimated average relative effect odds ratio across the individual components of 0.61 (95% confidence interval [CI], 0.54-0.71), P < .001. Among the 7 components of the primary outcome, experienced pairs of providers had significantly lower estimated odds of bleeding, infection, and mortality. CONCLUSIONS: Anesthesia care by experienced pairs was associated with fewer bleeding complications, fewer infections, shorter hospitalization, and reduced in-hospital mortality.

3.
4.
JAMA ; 324(22): 2327, 2020 Dec 08.
Artigo em Inglês | MEDLINE | ID: mdl-33289821
5.
Pain Med ; 21(Suppl 2): S53-S61, 2020 12 12.
Artigo em Inglês | MEDLINE | ID: mdl-33313729

RESUMO

BACKGROUND: Percutaneous peripheral nerve stimulation (PNS) is an analgesic modality involving the insertion of a lead through an introducer needle followed by the delivery of electric current after needle withdrawal. This modality has been used extensively to treat chronic pain, but only small series have been published involving postoperative pain. The ultimate objective of this study is to determine the postoperative effects of percutaneous PNS following moderately to severely painful ambulatory surgery within a real-world clinical practice setting. The primary hypothesis is that surgical pain and opioid consumption during the initial 7 days after surgery will be reduced by percutaneous PNS compared with usual and customary analgesia (dual primary outcome measures). DESIGN: A multicenter pragmatic effectiveness trial. We are randomizing participants having painful orthopedic surgical procedures of the upper and lower extremity to receive 14 days of either 1) electrical stimulation or 2) sham in a double-masked fashion. End points are being assessed at various time points over 12 postoperative months. SUMMARY: The postoperative experience will be much improved if percutaneous PNS provides potent analgesia while concurrently decreasing opioid requirements following painful surgery. Because this modality can be administered for up to 60 days at home, it may provide postoperative analgesia that outlasts surgical pain yet has relatively few risks and, unlike opioids, has no systemic side effects or potential for abuse, addiction, and overdose. Percutaneous PNS has the potential to revolutionize postoperative analgesia as it has been practiced for the past century. This study will inform key stakeholders regarding an evidence-based nonpharmacologic approach to the management of postoperative pain.

6.
Anesth Analg ; 2020 Oct 28.
Artigo em Inglês | MEDLINE | ID: mdl-33229859

RESUMO

BACKGROUND: Statins possess pleiotropic effects, which potentially benefit noncardiovascular conditions. Previous work suggests that statins reduce inflammation and prevent acute respiratory distress syndrome and infections. However, there is a paucity of data regarding potential benefits of statins on respiratory and infectious complications, particularly after noncardiac surgery. We therefore evaluated respiratory and other complications in noncardiac surgery patients taking or not taking statins preoperatively. METHODS: We obtained data from the Cleveland Clinic Perioperative Health Documentation System and evaluated medical records of 92,139 inpatients who had noncardiac surgery. Among these, 31,719 patients took statins preoperatively. Statin patients were compared to nonstatin patients on incidence of intraoperative use of albuterol and postoperative respiratory complications for primary analysis. Infectious complications, cardiovascular complications, in-hospital mortality, and duration of hospitalization were compared for secondary analyses, using inverse probability of treatment weighting to control for potential confounding. RESULTS: Statin use was associated with lower odds of intraoperative albuterol treatment (odds ratio [OR] = 0.89; 97.5% confidence interval [CI], 0.82-0.97; P = .001; number needed to treat [NNT] = 216). Postoperative respiratory complications were also less common (OR = 0.82; 98.75% CI, 0.78-0.87; P < .001). Secondarily, statin use was associated with lower odds of infections, cardiovascular complications, in-hospital mortality, and shorter duration of hospitalization. The interaction between statin use and sex was significant (with significance criteria P < .10) for all primary and secondary outcomes except intraoperative use of albuterol. CONCLUSIONS: Preoperative statin use in noncardiac surgical patients was associated with slightly reduced odds of postoperative respiratory, infectious, and cardiovascular complications. However, the NNTs were high. Thus, despite the fact that statins appeared to be associated with lower odds of various complications, especially cardiovascular complications, our results do not support using statins specifically to reduce noncardiovascular complications after noncardiac surgery.

7.
Asian J Anesthesiol ; 2020 Jul 24.
Artigo em Inglês | MEDLINE | ID: mdl-33176407

RESUMO

BACKGROUND: Extended-release local anesthetics allow for prolonged analgesia after a single administration. Although Asians demonstrate different pain thresholds than Caucasians, whether they have different postoperative local anesthetic analgesic effects has not been elucidated. OBJECTIVE: We aimed to compare the postoperative analgesic efficacy of liposomal bupivacaine on Asian and Caucasian adults, and the incidence of local anesthetic systemic toxicity (LAST) syndrome. METHODS: We conducted a retrospective, assessor-blinded cohort study of adult patients who received liposomal bupivacaine for surgery between 2012 and 2018. Asians and Caucasians were matched in a 1:1 ratio by clinical characteristics and surgery type. The primary outcome was pain management, defined as average pain score and opioid consumption during the initial 72 postoperative hours. The secondary outcome was the incidence of LAST syndrome. Reviewers were blinded to the ethnicity of the patient. RESULTS: After 1:1 propensity score matching, 130 Asians and 129 Caucasians were analyzed. All confounding variables were balanced, except for higher body mass index in the Asian group. Pain scores were lower (adjusted mean difference of -0.50 [97.5% CI, -0.98, -0.01]; superiority p = 0.011) and opioid consumption was not greater (geometric means ratio, 0.61 [97.5% CI, 0.36, 1.04]; non-inferiority p < 0.001) in Asian patients compared to Caucasian patients. Only one Caucasian patient was judged as having a potential case of LAST syndrome. The length of hospital stay and the incidence of additional complications were not different between the groups. CONCLUSION: Asian adults receiving liposomal bupivacaine as part of multimodal perioperative analgesia demonstrated lower pain scores compared to matching Caucasians, despite not having greater opioid consumption.

8.
Br J Anaesth ; 2020 Oct 10.
Artigo em Inglês | MEDLINE | ID: mdl-33051083

RESUMO

BACKGROUND: Myocardial infarction is the most common postoperative major vascular complication. Perioperative anaemia may contribute to cardiac supply-demand mismatch, and therefore myocardial injury. We therefore tested the hypothesis that the lowest in-hospital postoperative haemoglobin concentration is associated with a composite of non-fatal myocardial infarction and all-cause mortality within the first 30 days after noncardiac surgery. METHODS: We conducted a retrospective analysis of patients enrolled in the PeriOperative Ischemic Evaluation-2 (POISE-2) trial. We assessed the association between the lowest postoperative haemoglobin concentration during the initial hospitalisation and a composite of non-fatal myocardial infarction (Third Universal Definition) and all-cause mortality within 30 postoperative days, using a multivariable logistic regression model. RESULTS: We analysed 7227 patients from POISE-2, of whom 7.8% developed myocardial infarction; 1.5% died within 30 days. The composite primary outcome of non-fatal myocardial infarction and all-cause mortality occurred in 8.9% patients overall, ranging from 16% in patients with postoperative haemoglobin concentrations <88 g L-1 to 4.1% in patients with postoperative haemoglobin >113 g L-1. After adjusting for baseline factors, in patients with a lowest postoperative haemoglobin concentration <110 g L-1, each 10 g L-1 reduction in the lowest postoperative haemoglobin concentration was associated with a 1.46 (95% confidence interval: 1.37-1.56; P<0.001) fold increase in the odds of the composite outcome. In contrast, there was no significant relationship amongst patients with lowest postoperative haemoglobin concentration >110 g L-1. CONCLUSIONS: Postoperative anaemia may be a modifiable risk factor for non-fatal myocardial infarction and all-cause mortality.

10.
Br J Anaesth ; 2020 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-33039122

RESUMO

BACKGROUND: Myocardial injury after noncardiac surgery (MINS) is common, mostly silent, and a strong predictor of postoperative mortality. MINS appears to result from myocardial supply-demand mismatch. Recent data support restrictive perioperative transfusion strategies that can result in low postoperative haemoglobin concentrations. Whether low postoperative haemoglobin is associated with myocardial injury remains unknown. We therefore tested the hypothesis that anaemia is associated with an increased risk of myocardial injury in adults having noncardiac surgery. METHODS: We conducted a retrospective analysis of adults ≥45 yr old who had routine postoperative troponin T (TnT) monitoring after noncardiac surgery at the Cleverland Clinic (including those enrolled in the PeriOperative ISchemic Evaluation-2 Trial [POISE-2], the Safety of Addition of Nitrous Oxide to General Anaesthesia in At-risk Patients Having Major Non-cardiac Surgery [ENIGMA-II], Vascular Events In Noncardiac Surgery Patients Cohort Evaluation Study [VISION], and Anaesthetic Depth and Complications After Major Surgery [BALANCED] trial). Patients with baseline increase in TnT and non-ischaemic aetiologies for TnT increase were excluded. The association between postoperative haemoglobin concentration during the 3 initial postoperative days and the incidence of MINS (fourth-generation TnT ≥0.03 ng ml-1 judged as attributable to ischaemia) was assessed using a time-varying covariate Cox proportional hazards survival analysis. RESULTS: Among 6141 patients, 4480 were analysed. The incidence of MINS was 155/4480 (3.5%), ranging from 0/345 (0%) among patients whose lowest postoperative haemoglobin exceeded 13 g dl-1 to 52/611 (8.5%) in patients whose minimum postoperative haemoglobin was <8 g dl-1. The confounder-adjusted hazard ratio [95% confidence interval] for having MINS was 1.29 [1.16-1.42] for every 1 g dl-1 decrease in postoperative haemoglobin in a time-varying covariate analysis. Similar associations were identified in sensitivity analyses. CONCLUSION: Lower postoperative haemoglobin values are associated with MINS. Whether this association is modifiable by prevention or treatment of, anaemia remains to be determined.

11.
Pain ; 2020 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-33021563

RESUMO

Phantom limb pain is thought to be sustained by reentrant neural pathways which provoke dysfunctional reorganization in the somatosensory cortex. We hypothesized that disrupting reentrant pathways with a 6-day-long continuous peripheral nerve block reduces phantom pain 4 weeks after treatment. We enrolled patients who had an upper- or lower-limb amputation and established phantom pain. Each was randomized to receive a 6-day perineural infusion of either ropivacaine or normal saline. The primary outcome was the average phantom pain severity as measured with a Numeric Rating Scale (0-10) at 4 weeks, after which an optional crossover treatment was offered within the following 0-12 weeks. Pretreatment pain scores were similar in both groups, with a median [interquartile range] of 5.0 [4.0, 7.0] for each. After 4 weeks, average phantom limb pain intensity was a mean (SD) of 3.0 (2.9) in patients given local anesthetic versus 4.5 (2.6) in those given placebo (difference (95% CI) 1.3 (0.4, 2.2), P=0.003). Patients given local anesthetic had improved global impression of change and less pain-induced physical and emotional dysfunction, but did not differ on depression scores. For subjects who received only the first infusion (no self-selected crossover), the median decrease in phantom limb pain at 6 months for treated subjects was 3.0 [0, 5.0] vs. 1.5 [0, 5.0] for the placebo group; there appeared to be little residual benefit at 12 months. We conclude that a 6-day continuous peripheral nerve block reduces phantom limb pain as well as physical and emotional dysfunction for at least 1 month.

12.
Anesthesiology ; 133(6): 1214-1222, 2020 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-32960954

RESUMO

BACKGROUND: The Hypotension Prediction Index is a commercially available algorithm, based on arterial waveform features, that predicts hypotension defined as mean arterial pressure less than 65 mmHg for at least 1 min. We therefore tested the primary hypothesis that index guidance reduces the duration and severity of hypotension during noncardiac surgery. METHODS: We enrolled adults having moderate- or high-risk noncardiac surgery with invasive arterial pressure monitoring. Participating patients were randomized to hemodynamic management with or without index guidance. Clinicians caring for patients assigned to guidance were alerted when the index exceeded 85 (range, 0 to 100) and a treatment algorithm based on advanced hemodynamic parameters suggested vasopressor administration, fluid administration, inotrope administration, or observation. Primary outcome was the amount of hypotension, defined as time-weighted average mean arterial pressure less than 65 mmHg. Secondary outcomes were time-weighted mean pressures less than 60 and 55 mmHg. RESULTS: Among 214 enrolled patients, guidance was provided for 105 (49%) patients randomly assigned to the index guidance group. The median (first quartile, third quartile) time-weighted average mean arterial pressure less than 65 mmHg was 0.14 (0.03, 0.37) in guided patients versus 0.14 (0.03, 0.39) mmHg in unguided patients: median difference (95% CI) of 0 (-0.03 to 0.04), P = 0.757. Index guidance therefore did not reduce amount of hypotension less than 65 mmHg, nor did it reduce hypotension less than 60 or 55 mmHg. Post hoc, guidance was associated with less hypotension when analysis was restricted to episodes during which clinicians intervened. CONCLUSIONS: In this pilot trial, index guidance did not reduce the amount of intraoperative hypotension. Half of the alerts were not followed by treatment, presumably due to short warning time, complex treatment algorithm, or clinicians ignoring the alert. In the future we plan to use a lower index alert threshold and a simpler treatment algorithm that emphasizes prompt treatment.

14.
Minerva Anestesiol ; 2020 Sep 22.
Artigo em Inglês | MEDLINE | ID: mdl-32959636

RESUMO

Regional anesthesia has a very interesting long history, initially preferred over general anesthesia because of safety concerns, then for a period general anesthesia became safer and was preferred. The use of innovative technologies such as ultrasound technology has made the blocks safer and successful by directly visualizing targeted nerves and the location of local anesthetics. With the wide use of ultrasound in the regional anesthesia field success rate of peripheral nerve blocks increased and novel blocks techniques developed. Moreover, new extended-release local anesthetic agents have begun to be promising timeefficient and longer duration of analgesia with a single injection. In this article, we attempt to summarize some of the novel block techniques, pharmacological agents, and new technologies in the field of regional anesthesia.

16.
JAMA ; 324(4): 350-358, 2020 07 28.
Artigo em Inglês | MEDLINE | ID: mdl-32721009

RESUMO

Importance: Opioid-induced ventilatory depression and hypoxemia is common, severe, and often unrecognized in postoperative patients. To the extent that nonopioid analgesics reduce opioid consumption, they may decrease postoperative hypoxemia. Objective: To test the hypothesis that duration of hypoxemia is less in patients given intravenous acetaminophen than those given placebo. Design, Setting, and Participants: Randomized, placebo-controlled, double-blind trial conducted at 2 US academic hospitals among 570 patients who were undergoing abdominal surgery, enrolled from February 2015 through October 2018 and followed up until February 2019. Interventions: Participants were randomized to receive either intravenous acetaminophen, 1 g (n = 289), or normal saline placebo (n = 291) starting at the beginning of surgery and repeated every 6 hours until 48 postoperative hours or hospital discharge, whichever occurred first. Main Outcomes and Measures: The primary outcome was the total duration of hypoxemia (hemoglobin oxygen saturation [Spo2] <90%) per hour, with oxygen saturation measured continuously for 48 postoperative hours. Secondary outcomes were postoperative opioid consumption, pain (0- 10-point scale; 0: no pain; 10: the most pain imaginable), nausea and vomiting, sedation, minimal alveolar concentration of volatile anesthetic, fatigue, active time, and respiratory function. Results: Among 580 patients randomized (mean age, 49 years; 48% women), 570 (98%) completed the trial. The primary outcome, median duration with Spo2 of less than 90%, was 0.7 (interquartile range [IQR], 0.1-5.1) minutes per hour among patients in the acetaminophen group and 1.1 (IQR, 0.1-6.6) minutes per hour among patients in the placebo group (P = .29), with an estimated median difference of -0.04 (95% CI,-0.18 to 0.11) minutes per hour. None of the 8 secondary end points differed significantly between the acetaminophen and placebo groups. Mean pain scores within initial 48 postoperative hours were 4.2 (SD, 1.8) in the acetaminophen group and 4.4 (SD, 1.8) in the placebo group (difference, -0.28; 95% CI, -0.71 to 0.15); median opioid use in morphine equivalents was 50 mg (IQR, 18-122 mg) and 58 mg (IQR, 24-151 mg) , respectively, with a ratio of geometric means of 0.86 (95% CI, 0.61-1.21). Conclusions and Relevance: Among patients who underwent abdominal surgery, use of postoperative intravenous acetaminophen, compared with placebo, did not significantly reduce the duration of postoperative hypoxemia over 48 hours. The study findings do not support the use of intravenous acetaminophen for this purpose. Trial Registration: ClinicalTrials.gov Identifier: NCT02156154.


Assuntos
Acetaminofen/administração & dosagem , Analgésicos não Entorpecentes/administração & dosagem , Hipóxia/tratamento farmacológico , Complicações Pós-Operatórias/tratamento farmacológico , Analgésicos Opioides/efeitos adversos , Analgésicos Opioides/uso terapêutico , Método Duplo-Cego , Feminino , Humanos , Infusões Intravenosas , Masculino , Pessoa de Meia-Idade , Medição da Dor , Dor Pós-Operatória/tratamento farmacológico , Falha de Tratamento
17.
Ear Nose Throat J ; : 145561320934918, 2020 Jul 07.
Artigo em Inglês | MEDLINE | ID: mdl-32633658

RESUMO

BACKGROUND: Tonsillectomy is one of the most common surgical procedures in pediatric patients. The tonsillar retractor, which is routinely used during a tonsillectomy, applies high pressure to the patient's tongue and can lead to various complications. AIMS: This study aimed to explore tongue edema induced by the pressure applied by tonsillar retractor, using ultrasonography in pediatric patients undergoing tonsillectomy surgeries. MATERIALS AND METHODS: Sixty-one patients were included in the study. The tonsillectomy group included 31 patients who underwent tonsillectomy surgery, while the control group included 30 patients who underwent inguinal hernia and circumcision surgery. Submental coronal plane ultrasonography examinations of the tongue were performed twice for each patient. In the tonsillectomy group, the first examination of tongue area (TA1) was done immediately after intubation but before the placement of tonsillar retractor. The second examination (TA2) was done at the end of the tonsillectomy surgery after the removal of the tonsillar retractor but before extubation. In the control group, the first examination (TA1) was done immediately after intubation, whereas the second examination (TA2) was done at the end of the surgery before extubation. These results were compared with those for the control group. RESULTS: Groups were similar in terms of demographics and intubation duration. Groups did not significantly differ in terms of TA1 (P = .212), but they significantly differed in terms of TA2 (P = .000). They also significantly differed in terms of tongue edema defined as TA2 - TA1 (P = .000). CONCLUSIONS AND SIGNIFICANCE: Tonsillar retractor does cause tongue edema in tonsillectomy surgeries. This tongue edema seems to be a result of the pressure applied by the tonsillar retractor. This study is the first to demonstrate the possible role of ultrasonography examination in determining the tonsillar retractor-induced tongue edema in pediatric patients.

18.
Anesth Analg ; 131(3): 822-829, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32665475

RESUMO

BACKGROUND: Uncontrolled pain after noncardiac surgery activates the sympathetic nervous system, which causes tachycardia, hypertension, and increased cardiac contractility-all of which may increase myocardial oxygen demand. We therefore determined whether time-weighted average pain scores over the initial 72 postoperative hours are associated with myocardial injury after noncardiac surgery (MINS). METHODS: We conducted a retrospective cohort analysis of adults with routine postoperative troponin monitoring after noncardiac surgery under general, regional, or combined anesthesia at tertiary level centers in Cleveland from January 2012 to December 2015. Time-weighted average pain scores were calculated from all the available pain scores, typically at 4-hour intervals, until a troponin elevation was detected. MINS was defined as peak troponin T concentrations exceeding 0.03 ng/mL within 72 hours after surgery. We used a generalized linear mixed model to assess the association between pain and MINS with 3 hospitals as clusters, adjusting for potential confounders. RESULTS: Among 2892 eligible patients, 4.5% had myocardial injury within 72 hours after surgery. Higher time-weighted average pain scores were associated with increased hazard of myocardial injury. The estimated hazard ratio for a 1-unit increase in pain score was 1.12 (95% confidence interval [CI], 1.02-1.22; P = .013), adjusting for confounding variables. CONCLUSIONS: Among patients undergoing noncardiac surgery, time-weighted average pain scores within 72 hours after surgery were significantly associated with myocardial injury.


Assuntos
Dor Aguda/etiologia , Cardiopatias/etiologia , Dor Pós-Operatória/etiologia , Procedimentos Cirúrgicos Operatórios/efeitos adversos , Dor Aguda/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Feminino , Cardiopatias/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Dor Pós-Operatória/diagnóstico , Estudos Retrospectivos , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Troponina/sangue , Regulação para Cima
19.
Lancet ; 396(10245): 177-185, 2020 07 18.
Artigo em Inglês | MEDLINE | ID: mdl-32682483

RESUMO

BACKGROUND: Atrial fibrillation and delirium are common consequences of cardiac surgery. Dexmedetomidine has unique properties as sedative agent and might reduce the risk of each complication. This study coprimarily aimed to establish whether dexmedetomidine reduces the incidence of new-onset atrial fibrillation and the incidence of delirium. METHODS: A randomised, placebo-controlled trial was done at six academic hospitals in the USA. Patients who had had cardiac surgery with cardiopulmonary bypass were enrolled. Patients were randomly assigned 1:1, stratified by site, to dexmedetomidine or normal saline placebo. Randomisation was computer generated with random permuted block size 2 and 4, and allocation was concealed by a web-based system. Patients, caregivers, and evaluators were all masked to treatment. The study drug was prepared by the pharmacy or an otherwise uninvolved research associate so that investigators and clinicians were fully masked to allocation. Participants were given either dexmedetomidine infusion or saline placebo started before the surgical incision at a rate of 0·1 µg/kg per h then increased to 0·2 µg/kg per h at the end of bypass, and postoperatively increased to 0·4 µg/kg per h, which was maintained until 24 h. The coprimary outcomes were atrial fibrillation and delirium occurring between intensive care unit admission and the earlier of postoperative day 5 or hospital discharge. All analyses were intention-to-treat. The trial is registered with ClinicalTrials.gov, NCT02004613 and is closed. FINDINGS: 798 patients of 3357 screened were enrolled from April 17, 2013, to Dec 6, 2018. The trial was stopped per protocol after the last designated interim analysis. Among 798 patients randomly assigned, 794 were analysed, with 400 assigned to dexmedetomidine and 398 assigned to placebo. The incidence of atrial fibrillation was 121 (30%) in 397 patients given dexmedetomidine and 134 (34%) in 395 patients given placebo, a difference that was not significant: relative risk 0·90 (97·8% CI 0·72, 1·15; p=0·34). The incidence of delirium was non-significantly increased from 12% in patients given placebo to 17% in those given dexmedetomidine: 1·48 (97·8% CI 0·99-2·23). Safety outcomes were clinically important bradycardia (requiring treatment) and hypotension, myocardial infarction, stroke, surgical site infection, pulmonary embolism, deep venous thrombosis, and death. 21 (5%) of 394 patients given dexmedetomidine and 8 (2%) of 396 patients given placebo, had a serious adverse event as determined by clinicians. 1 (<1%) of 391 patients given dexmedetomidine and 1 (<1%) of 387 patients given placebo died. INTERPRETATION: Dexmedetomidine infusion, initiated at anaesthetic induction and continued for 24 h, did not decrease postoperative atrial arrhythmias or delirium in patients recovering from cardiac surgery. Dexmedetomidine should not be infused to reduce atrial fibrillation or delirium in patients having cardiac surgery. FUNDING: Hospira Pharmaceuticals.


Assuntos
Fibrilação Atrial/prevenção & controle , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Delírio/prevenção & controle , Dexmedetomidina/administração & dosagem , Hipnóticos e Sedativos/administração & dosagem , Esquema de Medicação , Feminino , Humanos , Infusões Intravenosas , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/prevenção & controle , Resultado do Tratamento
20.
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