Sedation-related Adverse Events Research Articles

A prospective, randomized, single-blinded study comparing the efficacy and safety of dexmedetomidine and propofol for sedation during endoscopic retrograde cholangiopancreatography

BackgroundBalanced propofol sedation is extensively used in endoscopic retrograde cholangiopancreatography (ERCP), but sedation-related adverse events (SRAEs) are common. In various clinical settings, the combination of dexmedetomidine with opioids and benzodiazepines has provided effective sedation with increased safety. The aim of this investigation was to compare the efficacy and safety of dexmedetomidine and propofol for sedation during ERCP.MethodsForty-one patients were randomly divided into two groups: the dexmedetomidine (DEX) group and the propofol (PRO) group. Patients in the DEX group received an additional bolus of 0.6 μg kg−1 dexmedetomidine followed by a dexmedetomidine infusion at 1.2 μg kg−1 h−1, whereas the PRO group received 1–2 mg kg−1 of propofol bolus followed by a propofol infusion at 2–3 mg kg−1 h−1. During ERCP, the primary outcome was the incidence of hypoxemia (SpO2 < 90% for > 10 s). Other intraoperative adverse events were also recorded as secondary outcomes, including respiratory depression (respiratory rate of < 10 bpm min−1), hypotension (MAP < 65 mmHg), and bradycardia (HR < 45 beats min−1).ResultsThe incidence of hypoxemia was significantly reduced in the DEX group compared to the PRO group (0% versus 28.6%, respectively; P = 0.032). Patients in the PRO group exhibited respiratory depression more frequently than patients in the DEX group (35% versus 81%, respectively; P = 0.003). There were no significant differences in terms of hypotension and bradycardia episodes between groups. During the procedures, the satisfaction scores of endoscopists and patients, as well as the pain and procedure memory scores of patients were comparable between groups.ConclusionIn comparison with propofol, dexmedetomidine provided adequate sedation safety with no adverse effects on sedation efficacy during ERCP.Trial registrationChinese Clinical Trial Registry, ChiCTR2200061468, 25/06/2022.

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

BackgroundProper 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.MethodsThe 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.ResultsThe 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).ConclusionThe 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.

Efficacy and safety of esketamine combined with propofol for curative endoscopic resection in colorectum: a prospective, randomized controlled trial

BackgroundCurative endoscopic resection is widely used to treat colonic polyps and early stage cancers. The anesthetic strategy commonly involves the use of propofol combined with a small dose of opioids for sedation. Adverse respiratory or cardiovascular events such as hypotension often occur when attempting to achieve the necessary level of sedation. Several studies have suggested its advantages owing to the anesthetic, analgesic, and sympathomimetic properties of esketamine. However, there are no reports on curative colorectal endoscopic resection. We designed this randomized controlled trial to assess the efficacy and safety of esketamine combined with propofol for sedation in patients undergoing curative colorectal endoscopic resection.MethodsA total of 166 patients who underwent curative colorectal endoscopic resection were randomly assigned to groups A (propofol + fentanyl) or E (propofol + esketamine). Ideal sedation was assessed using the MOAA/S scale and was achieved using TCI-propofol with different doses of fentanyl and esketamine. The propofol consumption and vasoactive drug dosages were recorded. Sedation-related times, adverse events, and satisfaction were recorded.ResultsOf the 160 patients, the total propofol consumption was significantly lower in group E (n = 81) (300 mg) than in group A (n = 79) (350 mg). Hypotension and bradycardia were significantly lower in Group E than in Group A. The groups showed no significant differences in other adverse events, induction time, recovery time, or patient or endoscopist satisfaction.ConclusionCompared to fentanyl, esketamine helps decrease propofol consumption and increases cardiovascular stability during curative colorectal endoscopic resection in American Society of Anesthesiologists Class I–III patients without affecting anesthesia, patient and endoscopist satisfaction, or other adverse events.Trial registrationThe study was retrospectively registered at the Chinese Clinical Trial Registry (www.chictr.org.cn; registration number: ChiCTR2300069014 on 03/03/2023).

A119 ACUTE COLONOC PSEUDO-OBSTRUCTION AFTER ENDOSCOPIC RESECTION OF A FULLY CIRCUMFERENTIAL LARGE NON-PEDUNCULATED COLORECTAL POLYP

Abstract Background Complex large non-pedunculated colorectal polyps (LNPCPs), including those involving the full circumference of the bowel, are now readily managed by minimally invasive endoscopic resection techniques. Established procedure-related adverse events include sedation related adverse events, deep mural injury, clinically significant post-resection bleeding, delayed perforation and serositis. An appreciation for potential procedure-related adverse events is critical to the effective implementation of these techniques. Aims To describe a case of acute colonic pseudo-obstruction after endoscopic resection of a fully circumferential LNPCP. Methods Case report and review of the literature Results A 91-year-old male with a history of atrial fibrillation, chronic kidney disease and suspected McKittrick-Wheelock syndrome underwent successful endoscopic mucosal resection (EMR) of a 100mm fully circumferential LNPCP in the sigmoid colon. Histopathology diagnosed a tubulovillous adenoma with high-grade dysplasia. After elective admission, he suffered from clinically significant post-EMR bleeding requiring 2 units of packed red blood cells. On post-operative day 1 he began to suffer from nausea, abdominal pain and obstipation. On examination, he was visibly distended. Abdominal X-ray revealed extensive gas-filled loops of small and large bowel with the absence of gas in the rectum. He was managed conservatively with nasogastric tube decompression. Total duration of hospital stay was 9 days. Conclusions Critical to the continued expansion of minimally invasive endoscopic resection techniques is an awareness for potential procedure-related adverse events. To our knowledge this is the first description of acute colonic pseudo-obstruction after endoscopic resection Funding Agencies None

Comparison of remimazolam and propofol combined with low dose esketamine for pediatric same-day painless bidirectional endoscopy: a randomized, controlled clinical trial.

Background: Remimazolam has shown similar or even superior properties to propofol in procedural sedation in adults, but few studies have been conducted in pediatric populations. Thus, we aimed to compare the effect and safety of remimazolam and propofol combined with low dose esketamine for pediatric same-day bidirectional endoscopy (BDE). Methods: Pediatrics <18years scheduled for elective BDE under sedation were included and randomly assigned to remimazolam group (R group) or propofol group (P group). The primary outcome was the success rate of sedation. Secondary outcomes include sedation-related information and adverse events. Mean arterial pressure (MAP), heart rate (HR), and perfusion index (PI) were recorded during sedation. Results: A total of 106 patients were enrolled and analyzed. The success rate of sedation was 100% in both groups. Compared with the P group, the induction time of the R group was significantly prolonged (p < 0.001), and the incidence of injection pain, intraoperative respiratory depression, hypotension and bradycardia was significantly lower (p < 0.001). The changes in MAP, HR and PI were relatively stable in the R group compared with the P group. Additionally, awake time significantly decreased with age by approximately 1.12 index points for each increase in age in the P group (p = 0.002) but not in the R group (p > 0.05). Furthermore, the decline in PI and PI ratio during BDE was related to body movement in the P group. Conclusion: Remimazolam combined with low dose esketamine has a non-inferior sedative effect than propofol for pediatric BDE, with no injection pain, less respiratory depression, more stable hemodynamics. Moreover, early detection of the decline in PI may avoid harmful stimulation under light anesthesia. Clinical trial registration: https://www.clinicaltrials.gov/study/NCT05686863?id=NCT05686863&rank=1, NCT05686863.

Supraglottic jet oxygenation and ventilation improves oxygenation during endoscopic retrograde cholangiopancreatography: a randomized controlled clinical trial

PurposeHypoxia is one of the most frequent adverse events under deep sedation in the semiprone position. We hypothesized that supraglottic jet oxygenation and ventilation (SJOV) via Wei nasal jet tube (WNJ) can reduce the incidence of hypoxia in patients under deep sedation during endoscopic retrograde cholangiopancreatography (ERCP).MethodsA total of 171 patients were divided into three groups: N group, supplementary oxygen via a nasopharyngeal airway (4–6 L/min); W group, supplementary oxygen via WNJ (4–6 L/min); WS group, SJOV via WNJ. The primary outcome was the incidence of adverse events, including sedation-related adverse events [SRAEs, hypoxemia (SpO2 = 75–89% lasted less than 60 s); severe hypoxemia (SpO2 < 75% at any time or SpO2 < 90% lasted more than 60 s] and subclinical respiratory depression (SpO2 = 90–95%). Other intraoperative and post-operative adverse events were also recorded as secondary outcomes.ResultsCompared with the N group, the incidence of hypoxemia and subclinical respiratory depression in the WS group was significantly lower (21% vs. 4%, P = 0.005; 27% vs. 6%, P = 0.002). Compared with Group W, the incidence of hypoxemia and subclinical respiratory depression in Group WS was also significantly less frequent (20% vs. 4%, P = 0.009; 21% vs. 6%, P = 0.014). No severe hypoxia occurred in the group WS, while four and one instances were observed in the group N and group W respectively. There were no significant differences in other adverse events among the three groups.ConclusionSJOV can effectively improve oxygenation during ERCP in deeply sedated semiprone patients.

Effects of adding low-dose esketamine to sufentanil and propofol sedation during cervical conization: a single-centre, randomized controlled trial

BackgroundCervical conization is a brief but painful procedure that can be performed under sufficient sedation with propofol and opioids. However, this sedation approach comes with a high risk of sedation-related adverse events (SRAEs). Esketamine, an N-methyl-d-aspartate (NMDA) receptor antagonist, causes less cardiorespiratory depression than opioids. The aim of this study was to assess the efficacy and safety of adding a low dose of esketamine to propofol and sufentanil sedation as an opioid-reduced regimen.MethodsA total of 122 consecutive patients with ASA I-II, body mass index < 30, and STOP-BANG score < 3 who underwent cervical conization were enrolled and randomly divided into Group S and Group ES. Using a closed-loop target-controlled infusion (TCI) pump with a target bispectral index (BIS) value of 60 ± 5, patients in Group S were sedated with 0.2 mcg·kg-1 sufentanil and propofol, while patients in Group ES were sedated with 0.15 mg·kg-1 esketamine, 0.1 mcg·kg-1 sufentanil and propofol. The primary outcome was the incidence and severity of SRAEs, while the secondary outcomes included effectiveness of sedation, awakening time, psychotomimetic side effects, postoperative pain, postoperative nausea and vomiting, and patient and gynaecologist satisfaction.ResultsData from 120 patients were analysed. The incidence of composite SRAEs was significantly higher in Group S than in Group ES (85.0% vs. 56.7%, P < 0.05). Furthermore, the severity of SRAEs was higher in Group S than in Group ES (P < 0.001). There were no significant differences in the effectiveness of sedation, awakening time, psychotomimetic side effects, postoperative pain, postoperative nausea and vomiting, or patient and gynaecologist satisfaction between the two groups.ConclusionAdding low-dose esketamine to propofol and sufentanil sedation reduces the incidence and severity of SRAEs in patients undergoing cervical conization, with equal sedation efficacy, recovery quality, and no additional psychomimetic side effects.Trial registrationChiCTR2000040457, 28/11/2020.

The Impact of Frailty on ERCP-Related Adverse Events: Findings From a National Cohort

Background and AimsEndoscopic retrograde cholangiopancreatography (ERCP) is an invasive procedure that has evolved from being primarily diagnostic to predominantly therapeutic, leading to an increased potential for ERCP-related adverse events. Frailty is an independent predictor of adverse outcomes, and its impact on ERCP-related outcomes requires investigation. This study evaluated the impact of frailty on ERCP-related adverse events. MethodsThe National Inpatient Sample from 2016 to 2019 was used to identify adult patients who underwent ERCP. Frailty was defined using the Frailty Risk Score. Outcomes were categorized into procedure-related adverse events, sedation-related adverse events, and hospitalization outcomes. Multivariate linear or logistic regression was used as appropriate. Stata, version 14.2, was used to perform analyses considering a 2-sided P < 0.05 to be statistically significant. ResultsAmong a total of 693,730 ERCPs performed, 870,30 (12.54%) were frail. Frail patients had higher odds of procedure-related adverse events, including hemorrhage (9.1/1000 vs 4.9/1000) and duodenal perforation, but not post-ERCP pancreatitis, bile duct perforation, cholecystitis, and cholangitis. Frailty imparted a higher risk of sedation-related respiratory failure, aspiration pneumonia, and the requirement of intubation and mechanical ventilation. Inpatient mortality was higher among frail patients (4.54% vs 1.03%), and they had prolonged hospital stays and higher hospitalization costs. ConclusionFrailty is associated with worse outcomes in patients undergoing ERCP, with higher risks of hemorrhage and sedation-related adverse events, in addition to increased resource utilization. Therefore, the findings of this study suggest strict adherence to guidelines governing anticoagulant management during the peri-endoscopic period, and sedative administration should be carefully monitored. Preprocedural optimization measures and diligent monitoring can minimize resource utilization and decrease periprocedural morbidity.

Protocolized Sedation Utilizing COMFORT-B Scale versus Non-protocol-directed Sedation in Mechanically Ventilated Children - An Open-label, Randomized Controlled Trial.

This study aimed to determine the effect of protocolized sedation using the COMFORT-B scale on the duration of mechanical ventilation (DMV). Eighty children with anticipated Duration of mechanical ventilation (DMV) >24h admitted to the Pediatric intensive care unit (PICU) were randomized into one group that received protocolized sedation (PS) using the COMFORT behavioural (COMFORT-B) scale, and another group that received non-protocolized sedation (NPS). The primary outcome was the impact on the DMV. The DMV was significantly lower in PS (PS: 3.5 [3-7] vs. NPS group: 8.5 [4.25-13.75] d; p = 0.008). The cumulative dose and duration of fentanyl in the PS group was significantly lower (median [IQR]; 120 [62.88-279.12] vs. 320.4 [110.88-851.52] μg/kg; p = 0.007 and 4 [2.25-7.75] vs. 8 [4-17.5] d; p = 0.009, respectively). The authors found a decrease in DMV and sedation related adverse events (SRAE) like ventilator associated pneumonia (VAP), accidental extubation, post-extubation stridor and dose and duration of sedative agents with PS.

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

BackgroundChildren 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. MethodsAn 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. ResultsOf 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. ConclusionThis 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 ImplicationsAs 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.

The efficacy of non-anesthesiologist-administered propofol sedation with a target-controlled infusion system during double-balloon endoscopic retrograde cholangiopancreatography

BackgroundThe sedation method used during double-balloon endoscopic retrograde cholangiopancreatography (DB-ERCP) differs among countries and/or facilities, and there is no established method. This study aimed to evaluate the efficacy of non-anesthesiologist-administered propofol (NAAP) sedation using a target-controlled infusion (TCI) system during DB-ERCP.MethodsThis retrospective study was conducted between May 2017 and December 2020 at an academic center. One hundred and fifty-six consecutive patients who underwent DB-ERCP were sedated by gastroenterologists using diazepam (n = 77) or propofol with a TCI system (n = 79), depending on the period. The primary endpoint was a comparison of poor sedation rates between the two groups. Poor sedation was defined as a condition requiring the use of other sedative agents or discontinuation of the procedure. Secondary endpoints were sedation-related adverse events and risk factors for poor sedation.ResultsPoor sedation occurred significantly more often in the diazepam sedation group (diazepam sedation, n = 12 [16%] vs. propofol sedation, n = 1 [1%]; P = 0.001). Vigorous body movements (3 or 4) (diazepam sedation, n = 40 [52%] vs. propofol sedation, n = 28 [35%]; P = 0.038) and hypoxemia (< 85%) (diazepam sedation, n = 7 [9%] vs. propofol sedation, n = 1 [1%]; P = 0.027) occurred significantly more often in the diazepam sedation group. In the multivariate analysis, age < 70 years old (OR, 10.26; 95% CI, 1.57–66.98; P = 0.015), BMI ≥ 25 kg/m2 (OR, 11.96; 95% CI, 1.67–85.69; P = 0.014), and propofol sedation (OR, 0.06; 95% CI, 0.01–0.58; P = 0.015) were associated factors for poor sedation.ConclusionsNAAP sedation with the TCI system during DB-ERCP was safer and more effective than diazepam sedation.

Medical disputes related to advanced endoscopic procedures with endoscopic retrograde cholangiopancreatography or endoscopic ultrasonography for the management of pancreas and biliary tract diseases.

This study aimed to evaluate the characteristics of endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic ultrasonography (EUS)-related adverse events (AEs) that eventually lead to medical disputes or claims on medical professional liability. Medical disputes for ERCP/EUS-related AEs filed in the Korea Medical Dispute Mediation and Arbitration Agency between April 2012 and August 2020 were evaluated using corresponding medical records. AEs were categorized into three sections: procedure-related, sedation-related, and safety-related AEs. Among a total of 34 cases, procedure-related AEs were 26 (76.5%; 12 duodenal perforations, 7 post-ERCP pancreatitis, 5 bleedings, 2 perforations combined with post-ERCP pancreatitis); sedation-related AEs were 5 (14.7%; 4 cardiac arrests, 1 desaturation), and safety-related AEs were 5 (8.8%; 1 follow-up loss for stent removal, 1 asphyxia, 1 fall). Regarding clinical outcomes, 20 (58.8%) were fatal and eventually succumbed to AEs. For the types of medical institutions, 21 cases (61.8%) occurred at tertiary or academic hospitals, and 13 (38.2%) occurred at community hospitals. The ERCP/EUS-related AEs filed in Korea Medical Dispute Mediation and Arbitration Agency showed distinct features: duodenal perforation was the most frequent AE, and clinical outcomes were fatal, resulting in at least more than permanent physical impairment.

Safety and efficacy of the combination of esketamine and propofol in procedural sedation/analgesia: a systematic review and meta-analysis.

This review and meta-analysis of randomized controlled trials (RCTs) assessed the side effects and efficacy of esketamine combined with propofol in procedural sedation and analgesia. The PubMed, MEDLINE, Embase and Cochrane Library databases were searched for relevant studies occurring between their inceptions and September 2022. The primary outcome was the incidence of sedation-related adverse events. Secondary outcomes included recovery time, total consumption of propofol and body movement. Data from a total of seven RCTs enrolling 808 patients were included in the meta-analysis. Pooling of data showed that compared with other drug regimens, the esketamine and propofol combination was associated with a reduction in the risk of hypotension (relative risk [RR]: 0.37, 95% confidence interval [CI]: 0.25 to 0.56) and bradycardia (RR: 0.34, 95% CI: 0.15 to 0.80) as well as an increase in the risk of agitation (RR: 6.29, 95% CI: 1.15 to 34.32). The results also indicated a decrease in propofol consumption (standardized mean difference: -1.45, 95% CI: -2.39 to -0.50) with the use of the esketamine and propofol combination. No significant difference was observed between the two groups in respiratory depression, nausea/vomiting, recovery time or body movement. Esketamine combined with propofol has an advantage in reducing the incidence of hypotension and bradycardia during procedural sedation and analgesia, but it may increase the risk of agitation in the recovery phase. More studies of high quality are needed before the widespread adoption of the combination of esketamine and propofol.

Utility of high-flow nasal oxygen in comparison to conventional oxygen therapy during upper gastrointestinal endoscopic procedures under sedation: A systematic review and meta-analyses.

Sedation and analgesia are the integral components of modern-day upper gastrointestinal (GI)endoscopic procedures. Irrespective of the sedative agent, hypoxia is the most commonly encountered unwarranted event with sedation. The current study intends to scrutinize whether high-flow nasal oxygen (HFNO) is advantageous for providing respiratory support during upper GI endoscopic procedures overother conventional low-flow oxygen delivery modalities, e.g. nasal cannula, facemask, etc. METHODS: An extensive screening of electronic databases was done till July 31, 2022, after enlisting in International prospective register of systematic reviews (PROSPERO) (CRD42021245409). Randomized controlled trials (RCT), comparative cohort studies, case series, cross-sectional studies and case-control studies evaluating the utility of HFNO during upper GI endoscopy under sedation were included in this meta-analysis. We retrieved eight randomized control studies and one longitudinal study with 3294 patients. The application of HFNO during endoscopy led to lesser incidence of desaturation spells (odds ratio [OR] = 0.23; 95% CI 0.11-0.48; I2 = 71%), reduced procedural interruption (OR = 0.11; 95% CI 0.02-0.60; I2 = 88%), betternadir SpO2 level during procedure (mean difference [MD] = 3.16; 95% CI 0.54-5.78; I2 = 73%), overall lesser incidence of sedation-related adverse events (OR = 0.63; 95% CI 0.42-0.93; I2 = 25%), with no significant impact on theduration of endoscopy (MD = 0.15; 95% CI - 0.02 to 0.31, I2 = 0%). HFNO is a novel option for upper GI endoscopy under sedation. CRD42021245409 ( https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021245409 ).

Sedation-Related Adverse Events in Gastrointestinal Endoscopy

Sedation-Related Adverse Events in Gastrointestinal Endoscopy

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

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). 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. 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). 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.).

Comparison of three sedation models for same-day painless bidirectional endoscopy: A multicenter randomized controlled trial.

Background and AimWe investigated the most beneficial propofol sedation model for same‐day painless bidirectional endoscopy (BDE).MethodsAsymptomatic participants scheduled for same‐day painless BDE examination from October 2020 to September 2021 were randomized to three groups: sedated esophagogastroduodenoscopy followed by unsedated colonoscopy (Group A); sedated esophagogastroduodenoscopy followed by sedated colonoscopy (Group B); and sedated esophagogastroduodenoscopy followed by sedated insertion colonoscopy (Group C). Patient discomfort, colonoscopy performance, doses of propofol, cardiovascular stress, anesthesia resuscitation, and sedation‐related adverse events were evaluated.ResultsA total of 3200 participants were analyzed. Baseline demographics, patient discomfort, cecal intubation rate, adenoma detection rate and sedation‐related adverse events were similar in the three groups. Propofol dose was the lowest in Group A (137.65 ± 36.865 mg) compared with Group B (177.71 ± 40.112 mg, P < 0.05) and Group C (161.63 ± 31.789 mg, P < 0.05). Decline in vital signs was most obvious in Group B during the procedure (P < 0.05). Recovery time was the shortest in Group A (5.01 ± 1.404 min) compared with Group B (9.51 ± 2.870 min, P < 0.05) and Group C (5.83 ± 2.594 min, P < 0.05); discharge time was the shortest in Group A (3.53 ± 1.685 min) compared with Group B (11.29 ± 5.172 min, P < 0.05) and Group C (6.47 ± 2.338 min, P < 0.05). Adenomas per positive patient of Group A (2.29 ± 1.055) and Group C (2.28 ± 0.931) were more than that in Group B (2.11 ± 0.946, P < 0.05).ConclusionsSedated esophagogastroduodenoscopy followed by unsedated colonoscopy is the superior model for same‐day painless BDE with the benefits of satisfactory patient comfort, reduced sedation dose, less cardiovascular stress, faster recovery, shorter discharge time and high colonoscopy quality.

The effectiveness of esketamine and propofol versus dezocine and propofol sedation during gastroscopy: A randomized controlled study.

Propofol is widely used in painless gastroscopy. However, sedation with propofol alone might increase the risk of respiratory and circulatory complications. This randomized clinical study compares the efficacy and safety of esketamine or dezocine combined with intravenous (IV) propofol in patients undergoing gastroscopy. A total of 102 patients were enrolled in this study and randomized into two groups. All patients were adults aged 18-64 years who underwent upper gastrointestinal gastroscopy. Patients were randomly assigned to two groups to receive esketamine (0.3mg/kg) combined with propofol (group E) or dezocine (0.05 mg/kg) combined with propofol (group D). In both groups, the drugs were administered intravenously. The primary outcome was the dose of propofol which provided a satisfactory sedative effect, both to the endoscopist and the patients. Secondary outcomes included recovery time, side effects (such as hypotension, nausea and vomiting and agitation), and the number of adverse circulatory and respiratory events. Data of 83 patients were analysed in the present study. Dosage of propofol required in group E (1.44 mg/kg ± 0.67 mg/kg) was significantly lower compared with that in group D (2.12 mg/kg ± 0.37 mg/kg) (p < 0.0001). There was no statistically significant difference in recovery time, side effects, and the frequency of sedation-related adverse events between the two groups. The study indicates that intravenous injection of propofol and esmketamine is more effective for gastroscopy. Use of esketamine reduces the total amount of propofol required in ASA I-II patients undergoing gastroscopy compared with single use of dezocine. It also provides more stable hemodynamics, without affecting the recovery time and side effects such as respiratory and circulatory adverse events. The study was registered at the Chinese Clinical Trial Registry (www.chictr.org.cn; registration number: ChiCTR2100051814) on 05/10/2021.

Incidence of sedation-related adverse events during ERCP with anesthesia assistance: a multicenter observational study

Anesthesia assistance is commonly used for ERCP. General anesthesia (GA) may provide greater airway protection but may lead to hypotension. We aimed to compare GA versus sedation without planned intubation (SWPI) on the incidence of hypoxemia and hypotension. We also explored risk factors for conversion from SWPI to GA. This observational study used data from the Multicenter Perioperative Outcomes Group. Adults with American Society of Anesthesiologists physical status class I to IV undergoing ERCP between 2006 and 2019 were included. We compared GA and SWPI on incidence of hypoxemia (oxygen saturation<90% for≥3 minutes) and hypotension (mean arterial pressure<65mm Hg for≥5 minutes) using joint hypothesis testing. The association between anesthetic approach and outcomes was assessed using logistic regression. The noninferiority delta for hypoxemia and hypotension was an odds ratio of 1.20. One approach was deemed better if it was noninferior on both outcomes and superior on at least 1 outcome. To explore risk factors associated with conversion from SWPI to GA, we constructed a logistic regression model. Among 61,735 cases from 42 institutions, 38,830 (63%) received GA and 22,905 (37%) received SWPI. The GA group had 1.27 times (97.5% confidence interval, 1.19-1.35) higher odds of hypotension but .71 times (97.5% confidence interval, .63-.80) lower odds of hypoxemia. Neither group was noninferior to the other on both outcomes. Conversion from SWPI to GA occurred in 6.5% of cases and was associated with baseline comorbidities and higher institutional procedure volume. GA for ERCP was associated with less hypoxemia, whereas SWPI was associated with less hypotension. Neither approach was better on the combined incidence of hypotension and hypoxemia.

Comparison of Procedural Sequences in Sedated Same-Day Bidirectional Endoscopy with Water-Exchange Colonoscopy: A Randomized Controlled Trial.

Background: Previous studies have favored esophagogastroduodenoscopy (EGD) followed by colonoscopy as the optimal sequence in bidirectional endoscopy (BDE) with air insufflation. However, the optimal sequence in same-day BDE with WE colonoscopy is unclear. Methods: A total of 200 patients undergoing BDE with propofol sedation from May 2018 to January 2021 were randomized to either the EGD-first group (n = 100) or the colonoscopy-first group (n = 100). Results: The EGD-first group required a longer cecal-intubation time (median 16.0 min vs. 13.7 min, p < 0.001) and a lower Boston Bowel Preparation Scale score (8.5 vs. 9, p = 0.030) compared with the colonoscopy-first group. However, the EGD-first group needed a significantly lower dose of propofol (200 mg vs. 250 mg, p < 0.001) and a shorter recovery time (7 min vs. 13.5 min, p < 0.001), resulting in a shorter turnover time of the endoscopy room (39.5 min vs. 42.6 min, p = 0.004). There were no differences in the sedation-related adverse events, patients’ satisfaction scores, adenoma-detection rates, or the outcomes of EGD between the two groups. Conclusions: During propofol-sedated BDE, EGD followed by WE colonoscopy was more efficient with a shorter turnover time despite a longer cecal-intubation time (NCT03638713).