Safety and efficacy of a low-dose combination of midazolam, alfentanil, and propofol for deep sedation of elderly patients undergoing ERCP.

BACKGROUND: Proper sedation of patients, particularly elderly individuals, who are more susceptible to sedation-related complications, is of significant importance in endoscopic retrograde cholangiopancreatography (ERCP). This study aims to assess the safety and efficacy of a low-dose combination of midazolam, alfentanil, and propofol for deep sedation in elderly patients undergoing ERCP, compared to a group of middle-aged patients. METHODS: The medical records of 610 patients with common bile duct stones who underwent elective ERCP under deep sedation with a three-drug regimen, including midazolam, alfentanil, and propofol at Shandong Provincial Third Hospital from January 2023 to September 2023 were retrospectively reviewed in this study. Patients were categorized into three groups: middle-aged (50-64 years, n = 202), elderly (65-79 years, n = 216), and very elderly (≥ 80 years, n = 192). Intraoperative vital signs and complications were compared among these groups. RESULTS: The three groups showed no significant difference in terms of intraoperative variation of systolic blood pressure (P = 0.291), diastolic blood pressure (P = 0.737), heart rate (P = 0.107), peripheral oxygen saturation (P = 0.188), bispectral index (P = 0.158), and the occurrence of sedation-related adverse events including hypotension (P = 0.170) and hypoxemia (P = 0.423). CONCLUSION: The results suggest that a low-dose three-drug regimen consisting of midazolam, alfentanil, and propofol seems safe and effective for deep sedation of elderly and very elderly patients undergoing ERCP procedures. However, further studies are required to verify these findings and clarify the benefits and risks of this method.

The effects of selected sedatives on basal and stimulated serum cortisol concentrations in healthy dogs.

Background: Hormone assessment is typically recommended for awake, unsedated dogs. However, one of the most commonly asked questions from veterinary practitioners to the endocrinology laboratory is how sedation impacts cortisol concentrations and the adrenocorticotropic hormone (ACTH) stimulation test. Butorphanol, dexmedetomidine, and trazodone are common sedatives for dogs, but their impact on the hypothalamic-pituitary-adrenal axis (HPA) is unknown. The objective of this study was to evaluate the effects of butorphanol, dexmedetomidine, and trazodone on serum cortisol concentrations. Methods: Twelve healthy beagles were included in a prospective, randomized, four-period crossover design study with a 7-day washout. ACTH stimulation test results were determined after saline (0.5 mL IV), butorphanol (0.3 mg/kg IV), dexmedetomidine (4 µg/kg IV), and trazodone (3-5 mg/kg PO) administration. Results: Compared to saline, butorphanol increased basal (median 11.75 µg/dL (range 2.50-23.00) (324.13 nmol/L; range 68.97-634.48) vs 1.27 µg/dL (0.74-2.10) (35.03 nmol/L; 20.41-57.93); P < 0.0001) and post-ACTH cortisol concentrations (17.05 µg/dL (12.40-26.00) (470.34 nmol/L; 342.07-717.24) vs 13.75 µg/dL (10.00-18.90) (379.31 nmol/L; 275.96-521.38); P ≤ 0.0001). Dexmedetomidine and trazodone did not significantly affect basal (1.55 µg/dL (range 0.75-1.55) (42.76 nmol/L; 20.69-42.76); P = 0.33 and 0.79 µg/dL (range 0.69-1.89) (21.79 nmol/L; 19.03-52.14); P = 0.13, respectively, vs saline 1.27 (0.74-2.10) (35.03 nmol/L; 20.41-57.93)) or post-ACTH cortisol concentrations (14.35 µg/dL (range 10.70-18.00) (395.86 nmol/L; 295.17-496.55); (P = 0.98 and 12.90 µg/dL (range 8.94-17.40) (355.86 nmol/L; 246.62-480); P = 0.65), respectively, vs saline 13.75 µg/dL (10.00-18.60) (379.31 nmol/L; 275.86-513.10). Conclusion: Butorphanol administration should be avoided prior to ACTH stimulation testing in dogs. Further evaluation of dexmedetomidine and trazodone's effects on adrenocortical hormone testing in dogs suspected of HPA derangements is warranted to confirm they do not impact clinical diagnosis.

Ethnic Disparities in Deep Sedation of Patients with Acute Respiratory Distress Syndrome in the United States: Secondary Analysis of a Multicenter Randomized Trial.

Rationale: Patients identified as Hispanic, the largest minority group in the United States, are more likely to die from acute respiratory distress syndrome (ARDS) than non-Hispanic patients. Mechanisms to explain this disparity remain unidentified. However, Hispanic patients may be at risk of overexposure to deep sedation because of language differences between patients and clinicians, and deep sedation is associated with higher ARDS mortality.Objective: We examined associations between Hispanic ethnicity and exposure to deep sedation among patients with ARDS.Methods: A secondary analysis was conducted of patients enrolled in the control arm of a randomized trial of neuromuscular blockade for ARDS across 48 U.S. hospitals. Exposure to deep sedation was measured over the first 5 days that a patient was alive and received mechanical ventilation. Multilevel mixed-effects models were used to evaluate associations between Hispanic ethnicity and exposure to deep sedation, controlling for patient characteristics.Results: Patients identified as Hispanic had approximately five times the odds of deep sedation (odds ratio, 4.98; 95% confidence interval, 2.02-12.28; P < 0.0001) on a given day, compared with non-Hispanic White patients. Hospitals with at least one enrolled Hispanic patient kept all enrolled patients deeply sedated longer than hospitals without any enrolled Hispanic patients (85.8% of ventilator-days vs. 65.5%; P < 0.001).Conclusions: Hispanic patients are at higher risk of exposure to deep sedation than non-Hispanic White patients. There is an urgent need to understand and address disparities in sedation delivery.

Supraglottic Jet Oxygenation and Ventilation to Minimize Hypoxia in Patients Receiving Flexible Bronchoscopy Under Deep Sedation: A 3-Arm Randomized Controlled Trial.

BACKGROUND: Hypoxia often occurs due to shared airway and anesthetic sedation-induced hypoventilation in patients receiving flexible bronchoscopy (FB) under deep sedation. Previous evidence has shown that supraglottic jet oxygenation and ventilation (SJOV) via Wei nasal jet tube (WNJ) reduces the incidence of hypoxia during FB. This study aimed to investigate the extent to which SJOV via WNJ could decrease the incidence of hypoxia in patients under deep sedation as compared to oxygen supplementation via WNJ alone or nasal catheter (NC) for oxygen supplementation during FB. METHODS: This was a single-center 3-arm randomized controlled trial (RCT). Adult patients scheduled to undergo FB were randomly assigned to 3 groups: NC (oxygen supplementation via NC), low-pressure low-flow (LPLF) (low-pressure oxygen supplementation via WNJ alone), or SJOV (high-pressure oxygen supplementation via WNJ). The primary outcome was hypoxia (defined as peripheral saturation of oxygen [Sp o2 ] <90% lasting more than 5 seconds) during FB. Secondary outcomes included subclinical respiratory depression or severe hypoxia, and rescue interventions specifically performed for hypoxia treatment. Other evaluated outcomes were sore throat, xerostomia, nasal bleeding, and SJOV-related barotraumatic events. RESULTS: One hundred and thirty-two randomized patients were included in 3 interventions (n = 44 in each), and all were included in the final analysis under intention to treat. Hypoxia occurred in 4 of 44 patients (9.1%) allocated to SJOV, compared to 38 of 44 patients (86%) allocated to NC, with a relative risk (RR) for hypoxia, 0.11; 98% confidence interval (CI), 0.02-0.51; P < .001; or to 27 of 44 patients (61%) allocated to LPLF, with RR for hypoxia, 0.15; 95% CI, 0.04-0.61; P < .001, respectively. The percentage of subclinical respiratory depression was also significantly diminished in patients with SJOV (39%) compared with patients with NC (100%) or patients with LPLF (96%), both P < .001. In SJOV, no severe hypoxia event occurred. More remedial interventions for hypoxia were needed in the patients with NC. Higher risk of xerostomia was observed in patients with SJOV. No severe adverse event was observed throughout the study. CONCLUSIONS: SJOV via WNJ effectively reduces the incidence of hypoxia during FB under deep sedation.

Effect of moderate versus deep sedation on recovery following outpatient gastroscopy in older patients: a randomized controlled trial.

BACKGROUND: Although gastrointestinal endoscopy with sedation is increasingly performed in older patients, the optimal level of sedation remains open to debate. In this study, our objective was to compare the effects of moderate sedation (MS) and deep sedation (DS) on recovery following outpatient gastroscopy in elderly patients. METHODS: In this randomized, partially blinded, controlled trial, we randomly divided 270 patients older than 60 years who were scheduled for elective outpatient gastroscopy into the MS or DS group based on the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. The primary outcome was the duration of stay in the post-anesthesia care unit (PACU). Secondary outcomes included the duration of the total hospital stay, frequency of retching, bucking, and body movements during the examination, endoscopist and patient satisfaction, and sedation-associated adverse events during the procedure. RESULTS: A total of 264 patients completed the study, of whom 131 received MS and 133 received DS. MS was associated with a shorter PACU stay [16.15 ± 9.01 min vs. 20.02 ± 11.13 min, P < 0.01] and total hospital stay [27.32 ± 9.86 min vs. 30.82 ± 12.37 min, P < 0.05], lesser hypoxemia [2.3% (3/131) vs. 12.8% (17/133), P < 0.01], use of fewer vasoactive drugs (P < 0.001), and more retching (P < 0.001). There was no difference in the incidence of bucking and body movements or endoscopist and patient satisfaction between the two groups. CONCLUSION: Compared to deep sedation, moderate sedation may be a preferable choice for American Society of Anesthesiologists (ASA) Grade I-III elderly patients undergoing outpatient gastroscopies, as demonstrated by shorter PACU stays and total hospital stays, lower sedation-associated adverse events, and similar levels of endoscopist and patient satisfaction.

A Retrospective Investigation of Patient- and Procedure-Related Factors Associated with Cardiorespiratory Complications in Pediatric Dental Patients Undergoing Deep Sedation.

Purpose: The purposes of this retrospective study were to investigate the incidence of cardiac and respiratory complications in pediatric patients undergoing dental procedures with deep propofol sedation and examine the factors that may lead to the development of these complica- tions. Methods: This study was carried out using the records of 421 pediatric patients who received dental treatment with deep sedation. Previously recorded cardiac/respiratory complications were noted. In addition, factors such as age, gender, body mass index (BMI), propofol induction/ infusion/total dose, operation duration, and the presence of comorbidities, which were investigated whether they affect these complications, were also noted. Data were analyzed with Mann-Whitney U, chi-square, and Fisher exact tests using univariable and multivariable logistic regression analyses. A level of five percent was considered to indicate statistical significance. Results: There were no significant differences between the cases with and without complications in terms of gender, age, BMI, total propofol dose, and operation time (P=0.887, P=0.827, P=0.213, P=0.581, and P=0.081, respectively). According to the multivariable logistic regression analysis, trisomy 21, heart disease, and asthma were found to be significant risk factors for the development of these complications (odds ratios equal 9.776, 3.257, and 14.646, respectively, 95 percent confidence interval; 3.807-25.100, 1.095-9.690, 4.110-52.188, respectively). Conclusion: Considering the limitations of this study, to minimize cardio-respiratory complications it is recommended that patients with comorbidities should not be managed with deep sedation and an open airway.

Success and safety of deep sedation as a primary anaesthetic approach for transvenous lead extraction: a retrospective analysis.

There is a rising number in complications associated with more cardiac electrical devices implanted (CIED). Infection and lead dysfunction are reasons to perform transvenous lead extraction. An ideal anaesthetic approach has not been described yet. Most centres use general anaesthesia, but there is a lack in studies looking into deep sedation (DS) as an anaesthetic approach. We report our retrospective experience for a large number of procedures performed with deep sedation as a primary approach. Extraction procedures performed between 2011 and 2018 in our electrophysiology laboratory have been included retrospectively. We began by applying a bolus injection of piritramide followed by midazolam as primary medication and would add etomidate if necessary. For extraction of leads a stepwise approach with careful traction, locking stylets, dilator sheaths, mechanical rotating sheaths and if needed snares and baskets has been used. A total of 780 leads in 463 patients (age 69.9 ± 12.3, 31.3% female) were extracted. Deep sedation was successful in 97.8% of patients. Piritramide was used as the main analgesic medication (98.5%) and midazolam as the main sedative (94.2%). Additional etomidate was administered in 15.1% of cases. In 2.2% of patients a conversion to general anaesthesia was required as adequate level of DS was not achieved before starting the procedure. Sedation related complications occurred in 1.1% (n = 5) of patients without sequalae. Deep sedation with piritramide, midazolam and if needed additional etomidate is a safe and feasible strategy for transvenous lead extraction.

Assessing the safety of deep sedation in outpatient pediatric oral health care.

BACKGROUND: Children are the patient subgroup with the lowest error tolerance regarding deep sedation (DS)-supported care. This study assessed the safety of DS-supported pediatric dental treatment carried out in an outpatient setting through retrospective review of patient charts. METHODS: An automated script was developed to identify charts of pediatric patients who underwent DS-supported dental procedures from 2017 through 2019 at a dental clinic. Charts were assessed for the presence of sedation-related adverse events (AEs). A panel of experts performed a second review and confirmed or refuted the designation of AE (by the first reviewer). AEs were classified with the Tracking and Reporting Outcomes of Procedural Sedation system. RESULTS: Of the 175 DS cases, 19 AEs were identified in 15 cases (8.60%). Using the Tracking and Reporting Outcomes of Procedural Sedation classification system, 7 (36.84%) events were related to the airway and breathing category, 9 (47.37%) were related to sedation quality (including a dizzy patient who fell at the checkout desk and sustained a head laceration), and 3 (15.79%) were classified as an allergy. CONCLUSION: This study suggests an AE (whether relatively minor or of potentially major consequence) occurs in 1 of every 12 DS cases involving pediatric patients, performed at an outpatient dental clinic. Larger studies are needed, in addition to root cause analyses. PRACTICAL IMPLICATIONS: As dentists increasingly pivot in the use of DS services from in-hospital to outpatient settings, patients expect comparable levels of safety. This work helps generate evidence to drive targeted efforts to improve the safety and reliability of pediatric outpatient sedation.

Safety of geriatric patients undergoing endobronchial ultrasound-guided transbronchial needle aspiration with deep sedation: a retrospective study.

BACKGROUND: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) can be performed in a wide range, from minimal sedation to general anesthesia. Advanced age increases perioperative risks related to anesthesia and is also associated with many pathological processes that further increase morbidity and mortality. The ideal sedation protocol for EBUS-TBNA has yet to be determined in geriatric patients. Deep sedation (DS) may increase the safety and performance of the procedure. There are limited studies evaluating the effectiveness and safety of EBUS-TBNA under DS in elderly patients. METHODS: 280 patients who underwent EBUS-TBNA under DS were included in this retrospective study. 156 patients aged 65 years and over (Group 1) and 124 patients under 45 (Group 2) were compared. Demographic data, comorbidities, pulmonary function tests (PFTs), hemodynamic measurements, and peripheral oxygen saturation (SpO2) before the procedure were evaluated. In addition, the duration of the EBUS-TBNA procedure, sedation agents and dosages, recovery time, and complications related to the procedure in the 24 h and applied medications and treatments were recorded. RESULTS: There was no difference in body mass index, EBUS-TBNA procedure duration, and recovery time between geriatric and young patients(p > 0.05). The proportion of female patients, pre-anesthesia SpO2, and PFTs were found to be significantly lower in geriatric patients(p < 0.05). ASA classification, frequency of comorbidities, and initial mean arterial pressure were found to be significantly higher in the geriatric group(p < 0.05). The propofol-ketamine combination was the most preferred sedative in both groups. The dose of propofol used in the regimen in which propofol was administered alone was found to be lower in the elderly group (p < 0.05). The increase in the HR was significant in Group 2 in the T4 and T5 periods with respect to T1 when the differences were compared (p < 0.05). As a complication, the frequency of high blood pressure during the procedure was higher in the elderly group (p < 0.05). CONCLUSIONS: The EBUS-TBNA procedure performed under DS was safe in elderly and young patients. Our study showed that the procedure and recovery times were similar in the elderly and young groups. The incidence of temporary high blood pressure during the procedure was higher in the elderly patients. The other complication rates during the procedure were similar in groups. Decreased propofol dose in the regimen using propofol alone has shown us that anesthetists are more sensitive to the administration of sedative agents in geriatric patients, taking into account comorbidities and drug interactions.

Sedation strategies for pulsed-field ablation of atrial fibrillation: focus on deep sedation with intravenous ketamine in spontaneous respiration.

AIMS: A standardized sedation protocol for pulsed-field ablation (PFA) of atrial fibrillation (AF) through irreversible cellular electroporation has not been well established. We report our experience of a protocol for deep sedation with ketamine in spontaneous respiration during the PFA of AF. METHODS AND RESULTS: All consecutive patients undergoing PFA for AF at our center were included. Our sedation protocol involves the intravenous administration of fentanyl (1.5 mcg/kg) and midazolam (2 mg) at low doses before local anesthesia with lidocaine. A ketamine adjunct (1 mg/kg) was injected about 5 minutes before the first PFA delivery. We enrolled 66 patients (age = 59 ± 9 years, 78.8% males, body mass index = 28.8 ± 5 kg/m2, fluoroscopy time = 21[15-30] min, skin-to-skin time = 75[60-100] min and PFA LA dwell time = 25[22-28] min). By the end of the procedure, PVI had been achieved in all patients by means of PFA alone. The mean time under sedation was 56.4 ± 6 min, with 50 (76%) patients being sedated for less than 1 hour. A satisfactory Ramsey Sedation Scale level before ketamine infusion was achieved in all patients except one (78.8% of the patients with rank 3; 19.7% with rank 2). In all procedures, the satisfaction level was found to be acceptable by both the patient and the primary operator (Score = 0 in 98.5% of cases). All patients reported none or mild pain. No major procedure or anesthesia-related complications were reported. CONCLUSION: Our standardized sedation protocol with the administration of drugs with rapid onset and pharmacological offset at low doses was safe and effective, with an optimal degree of patient and operator satisfaction. CLINICAL TRIAL REGISTRATION: Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice (ATHENA). URL: http://clinicaltrials.gov/Identifier: NCT05617456.

Anesthetic Management and Deep Sedation After Emergence From General Anesthesia: A Retrospective Cohort Study.

BACKGROUND: Residual deep sedation during anesthesia recovery may predict postoperative complications. We examined the incidence and risk factors for deep sedation after general anesthesia. METHODS: We retrospectively reviewed health records of adults who underwent procedures with general anesthesia and were admitted to the postanesthesia care unit from May 2018 to December 2020. Patients were dichotomized by Richmond Agitation-Sedation Scale (RASS) score: ≤-4 (deeply sedated/unarousable) or ≥-3 (not deeply sedated). Anesthesia risk factors for deep sedation were assessed with multivariable logistic regression. RESULTS: Of the 56,275 patients included, 2003 had a RASS ≤-4 (35.6 [95% CI, 34.1-37.2] cases per 1000 anesthetics administered). On adjusted analyses, the likelihood of a RASS ≤-4 increased when more soluble halogenated anesthetics were used. Compared with desflurane without propofol, the odds ratio (OR [95% CI]) for a RASS ≤-4 was higher with sevoflurane (1.85 [1.45-2.37]) and isoflurane (4.21 [3.29-5.38]) without propofol. Compared with desflurane without propofol, the odds of a RASS ≤-4 further increased with use of desflurane-propofol (2.61 [1.99-3.42]), sevoflurane-propofol (4.20 [3.28-5.39]), isoflurane-propofol (6.39 [4.90-8.34]), and total intravenous anesthesia (2.98 [2.22-3.98]). A RASS ≤-4 was also more likely with the use of dexmedetomidine (2.47 [2.10-2.89]), gabapentinoids (2.17 [1.90-2.48]), and midazolam (1.34 [1.21-1.49]). Deeply sedated patients discharged to general care wards had higher odds of opioid-induced respiratory complications (2.59 [1.32-5.10]) and higher odds of naloxone administration (2.93 [1.42-6.03]). CONCLUSIONS: Likelihood of deep sedation after recovery increased with intraoperative use of halogenated agents with higher solubility and increased further when propofol was concomitantly used. Patients who experience deep sedation during anesthesia recovery have an increased risk of opioid-induced respiratory complications on general care wards. These findings may be useful for tailoring anesthetic management to reduce postoperative oversedation.

Modified Manual Chest Compression for Prevention and Treatment of Respiratory Depression in Patients Under Deep Sedation During Upper Gastrointestinal Endoscopy: Two Randomized Controlled Trials.

BACKGROUND: We aimed to determine the preventive and therapeutic efficacy of modified manual chest compression (MMCC), a novel noninvasive and device-independent method, in reducing oxygen desaturation events in patients undergoing upper gastrointestinal endoscopy under deep sedation. METHODS: A total of 584 outpatients who underwent deep sedation during upper gastrointestinal endoscopy were enrolled. In the preventive cohort, 440 patients were randomized to the MMCC group (patients received MMCC when their eyelash reflex disappeared, M1 group) or control group (C1 group). In the therapeutic cohort, 144 patients with oxygen desaturation of a Sp o2 < 95% were randomized to MMCC group (patients who subsequently received MMCC, M2 group) or the conventional treatment group (C2 group). The primary outcomes were the incidence of desaturation episodes with an Sp o2 < 95% for the preventive cohort and the time spent below 95% Sp o2 for the therapeutic cohort. Secondary outcomes included the incidence of gastroscopy withdrawal and diaphragmatic pause. RESULTS: In the preventive cohort, MMCC reduced the incidence of desaturation episodes <95% (14.4% vs 26.1%; RR, 0.549; 95% confidence interval [CI], 0.37-0.815; P = .002), gastroscopy withdrawal (0% vs 2.29%; P = .008), and diaphragmatic pause at 30 seconds after propofol injection (74.5% vs 88.1%; RR, 0.846; 95% CI, 0.772-0.928; P < .001). In the therapeutic cohort, patients who received MMCC had a significantly shorter time spent below 95% Sp o2 (40 [20-69] seconds vs 91 [33-152] seconds, median difference [95% CI], -39 [-57 to -16] seconds, P < .001), a lower incidence of gastroscopy withdrawal (0% vs 10.4%, P = .018), and more enhanced diaphragmatic movement at 30 seconds after Sp o2 <95% (1.11 [0.93-1.4] cm vs 1.03 [0.7-1.24] cm; median difference [95% confidence interval], 0.16 [0.02-0.32] cm; P = .015). CONCLUSIONS: MMCC may exert preventive and therapeutic effects against oxygen desaturation events during upper gastrointestinal endoscopy.

A comparison of the success rate of pneumatic reduction in intussusception between general anesthesia and deep sedation: a randomized controlled trial.

PURPOSE: This study was aimed to compare the success rate between patients who underwent general anesthesia and deep sedation. METHODS: Patients who were diagnosed with intussusception and had no contraindications would receive non-operative treatment first by undergoing pneumatic reduction. The patients were then split in to two groups: one group underwent general anesthesia (GA group), while the other underwent deep sedation (SD group). This study was a randomized controlled trial which compared success rate between two groups. RESULTS: A total of 49 episodes diagnosed with intussusception were random into 25 episodes in GA group and 24 episodes in SD group. There was no significant difference in baseline characteristic between the two groups. The success rates of GA group and SD group were equally 88.0% (p = 1.00). Sub-analysis of the success rate was lower in the patients with high-risk score for failed reduction. (Chiang Mai University Intussusception (CMUI) failed score in success VS failed = 6.9 ± 3.2 vs. 10.3 ± 3.0 p = 0.017). CONCLUSION: General anesthesia and deep sedation offered similar success rates. In cases of high risk of failure, general anesthesia should be considered to accommodate the switch to surgical management in the same setting if the non-operative approach fails. The appropriate treatment and sedative protocol also increase the success of reduction.

Green discoloration of the urine following sedation with propofol for colonoscopy.

Propofol (2,6-diisopropylphenol) is the most widely used drug for endoscopic procedures under deep sedation. We present the clinical case of an 83-year-old man who underwent a colonoscopy under sedation with propofol, observing a green discolouration of the urine during the procedure.

Safety of endoscopist-administered deep sedation with propofol in ASA III patients

Introduction: deep sedation controlled by the endoscopist is safe in patients with low anesthetic risk (ASA I-II). However, scarce evidence is available in patients with intermediate risk (ASA III).Objective: to evaluate the safety of deep sedation with propofol controlled by the usual endoscopy staff (endoscopist, nurse, assistant) in outpatients classified as ASA III and the risk factors for the occurrence of complications during deep sedation.Patients and methods: this observational and single-center cross-sectional study included consecutive patients undergoing non-complex procedures in which deep sedation was administered by the endoscopy staff. Patients were divided into group I (ASA = III) and group II (ASA < III).Results: a total of 562 patients were included and 80 (14.2 %) were in group I. Complications related to deep sedation were more frequent in group I (23.8 % vs 14.5 %; p = 0.036), mainly mild desaturations (13.8 % vs 7.5 %; p = 0.058). Emergency intervention or death were not registered. The adjusted analysis identified age as the only independent baseline risk factor for developing global adverse events.Conclusion: ASA III patients developed more sedation-related complications than ASA I-II patients. However, these complications were mild and did not prevent the correct performance of the procedure. (AU)

Randomized trial comparing general anesthesia with anesthesiologist-administered deep sedation for ERCP in average-risk patients.

BACKGROUND AND AIMS: General anesthesia (GA) or monitored anesthesia care (MAC) is increasingly used to perform ERCP. The definitive choice between the 2 sedative types remains to be established. This study compared outcomes of GA with MAC in ERCP performed in patients at average risk for sedation-related adverse events (SRAEs). METHODS: At a tertiary referral center, patients with American Society of Anesthesiologists (ASA) class ≤III were randomly assigned to undergo ERCP with MAC or GA. The main outcome was a composite of hypotension, arrhythmia, hypoxia, hypercapnia, apnea, and procedural interruption or termination defined as SRAEs. In addition, ERCP procedural time, success, adverse events, and endoscopist and patient satisfaction were compared. RESULTS: Of 204 randomized, 203 patients were evaluated for SRAEs (MAC, n = 96; GA, n = 107). SRAEs developed in 35% of the MAC cohort (34/96) versus 9% in the GA cohort (10/107), which was statistically significant (P < .001). Mean induction time for GA was significantly longer than that for MAC (10.3 ± 10 minutes vs 6.5 ± 10.8 minutes, respectively; P < .001). ERCP procedure time, recovery time, cannulation time and success, and procedure-related adverse events were not statistically different between the 2 sedative groups. The use of GA improved endoscopist and patient satisfaction (P < .001). CONCLUSION: GA is safe with fewer SRAEs than MAC in patients with ASA scores ≤III undergoing ERCP. Apart from prolonging induction time, use of GA does not change the procedural success or ERCP-related adverse events and offers greater endoscopist and patient satisfaction. Hence, GA is a consideration in patients undergoing ERCP in this population group. (Clinical trial registration number: NCT04099693.).

High-flow nasal cannula versus standard low-flow nasal cannula during deep sedation in patients undergoing radiofrequency atrial fibrillation catheter ablation: a single-centre randomised controlled trial.

BACKGROUND: To our knowledge, there are few trials studying the effect of high-flow nasal cannula (HFNC) during deep sedation. Our hypothesis is that high-flow nasal cannula (HFNC) will prevent hypoxemia and desaturation as compared to low-flow nasal cannula (LFNC) during prolonged deep sedation in patients with atrial fibrillation undergoing radiofrequency catheter ablation (RFCA). METHODS: A single-centre, randomised controlled trial with HFNC as the intervention and LFNC as the control group. A total of 94 adult patients per group undergoing elective radiofrequency atrial fibrillation catheter ablation under deep sedation. will be included. The primary outcome is the lowest oxygen saturation (SpO2). Secondary outcomes are as follows: the duration of lowest SpO2, cross over from oxygen therapy in both directions, incidence of SpO2 below 90% > 60 seconds, adverse sedation events, adverse effects of HFNC, mean CO2, peak CO2 and patients experience with oxygen therapy. The study will take place during the 2-day admission period for RFCA. Patients can fill out their questionnaires in the first week after treatment. DISCUSSION: HFNC is increasingly used as a technique for oxygen delivery in procedural sedation and analgesia. We hypothesise that HFNC is superior to the standard treatment LFNC in patients under deep sedation with respect to the incidence of desaturation. To our knowledge, there are no adequately powered clinical trial studies on the effects of HFNC in prolonged deep sedation. TRIAL REGISTRATION: ClinicalTrials.gov NCT04842253. Registered on 04 April 2021.

Comparison of effectiveness, cost and safety between moderate sedation and deep sedation under esophagogastroduodenoscopy in Chinese population: a quasi-experimental study.

OBJECTIVE: Most endoscopists routinely perform moderate or deep sedation for esophagogastroduodenoscopy (EGD). Considering that there is no consensus on the optimal sedation depth and it varies from country to country, our study aims to compare the effectiveness, cost and safety of these two sedation methods in the Chinese population. METHODS: This quasi-experimental study included a total of 556 eligible patients from July 2020 to June 2021, and they entered the moderate sedation group or deep sedation group based on their choices. Baseline information, scores of Patient Satisfaction with Sedation Instrument (PSSI) and Clinician Satisfaction with Sedation Instrument (CSSI), examination time, sedation time, recovery time, expenses before medicare reimbursement, hypoxaemia and hypotension were compared between the two groups. Propensity Score Matching (PSM) analysis was conducted to balance the confounding factors. RESULTS: After PSM, 470 patients were involved in the analysis, with 235 for each group. The moderate sedation was clearly superior to the deep sedation group in terms of PSSI score (98.00 ± 0.94 vs. 97.29 ± 1.26), CSSI score (98.00 ± 0.78 vs. 97.67 ± 1.30), sedation time (11.90 ± 2.04 min vs. 13.21 ± 2.75 min), recovery time (25.40 ± 3.77 min vs. 28.0 ± 4.85 min), expenses (433.04 ± 0.00 Yuan vs. 789.85 ± 0.21 Yuan), with all p < .001. Examination time was not significantly different between the two groups (p = .124). In addition, the moderate sedation group had a lower occurrence rate of hypoxaemia (0.36% vs. 3.27%, p = .010) and hypotension (17.44% vs. 44.00%, p < .001) compared to the deep sedation group. CONCLUSIONS: Moderate sedation presented better effectiveness and safety and lower cost, and thereby it should be recommended as a widely used sedation method in clinical practice in China. Trial registration: This trial was registered on http://www.chictr.org.cn/index.aspx (ChiCTR2000038050).

Deep sedation predicts pressure injury in patients admitted to intensive care units.

BACKGROUND: Patients in intensive care units (ICU) are frequently prescribed sedatives, which might increase the risk for pressure injury (PI). Although the association between sedation and incidence of PI has been noted, the adequate sedation level to prevent the incidence of PI in patients admitted to ICU is still unclear. AIM: This study aimed to investigate the association between fluctuating sedation levels and the incidence of PI in patients admitted to ICU. STUDY DESIGN: We retrospectively reviewed the medical records of 104 patients admitted to ICU. Data regarding the length of ICU stay (LOS) and comorbid infection were abstracted from medical records. The Richmond Agitation-Sedation Scale (RASS) was scored twice per day, and the standardized RASS (S-RASS, summation of RASS values divided by the number of samples) was used to evaluate changes in sedation levels. RESULTS: Among the 104 included patients, 65 patients (62.5%) were male (median age: 68.0 years), and 13 patients (12.5%) had PI during ICU admission. S-RASS scores were lower in patients with PI than in those without PI (P = .0001) even after adjustment for confounders (OR [95%CI]: 0.14 [0.03-0.58], P = .006). The LOS and infections were higher in patients with PI than in those without PI (P < .0001 and P = .005, respectively). The cut-off value of S-RASS for PI incidence was -3.2 (sensitivity: 88%; specificity: 85%), and a significant predictor of PI incidence (HR [95%CI]: 20.07 [2.53-159.11], P = .005). CONCLUSIONS: Deeper sedation levels based on S-RASS scores, which account for the effects of fluctuating sedation levels, were a strong, highly accurate predictor of PI incidence in patients admitted to ICU. RELEVANCE TO CLINICAL PRACTICE: Assessing fluctuations in the level of sedation using the S-RASS might help to identify sedative-induced PI in patients admitted to ICU.

Safety of endoscopist-administered deep sedation with propofol in ASA III patients.

INTRODUCTION: deep sedation controlled by the endoscopist is safe in patients with low anesthetic risk (ASA I-II). However, scarce evidence is available in patients with intermediate risk (ASA III). OBJECTIVE: to evaluate the safety of deep sedation with propofol controlled by the usual endoscopy staff (endoscopist, nurse, assistant) in outpatients classified as ASA III and the risk factors for the occurrence of complications during deep sedation. PATIENTS AND METHODS: this observational and single-center cross-sectional study included consecutive patients undergoing non-complex procedures in which deep sedation was administered by the endoscopy staff. Patients were divided into group I (ASA = III) and group II (ASA < III). RESULTS: a total of 562 patients were included and 80 (14.2 %) were in group I. Complications related to deep sedation were more frequent in group I (23.8 % vs 14.5 %; p = 0.036), mainly mild desaturations (13.8 % vs 7.5 %; p = 0.058). Emergency intervention or death were not registered. The adjusted analysis identified age as the only independent baseline risk factor for developing global adverse events. CONCLUSION: ASA III patients developed more sedation-related complications than ASA I-II patients. However, these complications were mild and did not prevent the correct performance of the procedure.