Eberl Susanne, Koers Lena, van Hooft Jeanin E, de Jong Edwin, Schneider Thomas, Hollmann Markus W, Preckel Benedikt
Department of Anesthesiology, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, Amsterdam, 1100 DD, The Netherlands.
Department of Gastroenterology & Hepatology, Academic Medical Centre, University of Amsterdam, Meibergdreef 9, Amsterdam, 1100 DD, The Netherlands.
Trials. 2017 Oct 11;18(1):472. doi: 10.1186/s13063-017-2197-8.
Endoscopic retrograde cholangiopancreatography (ERCP) is a gastrointestinal procedure that requires a relatively motionless patient during the intervention. Deep sedation by intravenous propofol combined with an opioid has recently become the preferred sedation technique. However, when high doses of propofol are used, side effects, namely respiratory depression, may occur. Esketamine has hypnotic, analgesic, and sympathomimetic effects. Our assumption is that a combination of propofol with esketamine reduces the dosage of individual drugs, thereby minimizing sedation side effects while keeping the same satisfaction level of patients and endoscopists.
METHODS/DESIGN: The study will be performed as a randomized controlled multicenter trial. Patients undergoing ERCP, ≥ 18 years old, with American Society of Anesthesiologists (ASA) classification I-III will be randomized after written informed consent to group K (propofol/esketamine) or to group A (propofol/alfentanil). The primary outcome, reflecting effectiveness of sedation, is the total dose of propofol. Secondary outcome parameters are patients' and endoscopists' satisfaction with the procedure and the number of sedation-related pulmonary and cardiovascular events. Data on sedation-related events are collected by recording of oxygen saturation (SpO), respiratory rate (RR), end-tidal CO (etCO), heart rate (HR), arrhythmias (electrocardiogram (ECG)), and non-invasive blood pressure (NIBP) measurements. Satisfaction parameters are collected by means of questionnaires before and after the procedure and on the following day.
Esketamine is known for its effective anesthetic and analgesic effects maintaining spontaneous breathing and airway reflexes. Due to an increase in sympathetic tone, hypotension and cardiac depression is less common. Unfortunately esketamine is also known for its psychotomimetic effects. We aim to demonstrate that the combination of esketamine with propofol for sedation in patients subjected to ERCP interventions is nevertheless superior to a combination of propofol with an opioid.
Nederland's Trial Register, NTR5486 . Registered on 17 September 2015.
内镜逆行胰胆管造影术（ERCP）是一种胃肠道手术，在手术过程中需要患者相对保持静止。静脉注射丙泊酚联合阿片类药物进行深度镇静最近已成为首选的镇静技术。然而，当使用高剂量丙泊酚时，可能会出现副作用，即呼吸抑制。艾司氯胺酮具有催眠、镇痛和拟交感神经作用。我们的假设是，丙泊酚与艾司氯胺酮联合使用可降低各药物的剂量，从而在保持患者和内镜医师相同满意度的同时，将镇静副作用降至最低。
方法/设计：本研究将作为一项随机对照多中心试验进行。年龄≥18岁、美国麻醉医师协会（ASA）分级为I - III级的接受ERCP手术的患者，在签署书面知情同意书后，将被随机分为K组（丙泊酚/艾司氯胺酮）或A组（丙泊酚/阿芬太尼）。反映镇静效果的主要结局指标是丙泊酚的总剂量。次要结局参数包括患者和内镜医师对手术的满意度以及与镇静相关的肺部和心血管事件的数量。通过记录血氧饱和度（SpO）、呼吸频率（RR）、呼气末二氧化碳（etCO）、心率（HR）、心律失常（心电图（ECG））和无创血压（NIBP）测量来收集与镇静相关事件的数据。满意度参数通过手术前后及术后次日的问卷调查收集。
艾司氯胺酮以其有效的麻醉和镇痛作用、维持自主呼吸和气道反射而闻名。由于交感神经张力增加，低血压和心脏抑制较少见。不幸的是，艾司氯胺酮也以其拟精神作用而闻名。我们旨在证明，在接受ERCP手术的患者中，艾司氯胺酮与丙泊酚联合镇静仍优于丙泊酚与阿片类药物的联合。
荷兰试验注册库，NTR5486。于2015年9月17日注册。
