Table_1_Effects of opioid-free propofol or remimazolam balanced anesthesia on hypoxemia incidence in patients with obesity during gastrointestinal endoscopy: A prospective, randomized clinical trial.docx

There are presently no consensuses on the optimal sedation strategy for obese patients during gastrointestinal endoscopy. This study aim to explore the effects of opioid-free propofol or remimazolam balanced anesthesia on hypoxemia incidence in patients with obesity. A total of 264 patients were randomized to remimazolam + esketamine group (group R) or propofol + esketamine group (group P). Anesthesia in group P was administrated by propofol, esketamine and in group R by remimazolam, esketamine. The primary outcome was incidence of hypoxemia. Secondary outcomes were the time to loss of consciousness (LoC) and to recovery and the incidence of intraoperative and postoperative adverse reactions. We found the incidence of mild hypoxemia in group R was similar to that in group P (14.2% vs. 11.5%, p = 0.396). The incidence of severe hypoxemia in group R was significantly lower than Group P (4.2% vs. 9.2%, p = 0.019). The time to LoC in group R was longer than group P [Median (interquartile range, IQR): 53 s (45 to 61) vs. 50 s (42 to 54), p = 0.001]. The time to recovery from anesthesia in group R was less than group P [Median (IQR): 48 min (41 to 58) vs. 55.5 min (46 to 67), p<0.001]. There was no significant difference in the incidence of adverse events (p > 0.05 for all). We concluded that compared with propofol combined with esketamine, remimazolam combined with esketamine can reduce the incidence of severe hypoxemia during gastrointestinal endoscopy in obese patients.
Clinical Trial Registration:www.chictr.org.cn, Identifier: ChiCTR2200065575.

目前，学界对于肥胖患者行胃肠内镜检查时的最佳镇静策略尚未达成共识。本研究旨在探讨无阿片类药物的丙泊酚（propofol）或瑞马唑仑（remimazolam）复合麻醉对肥胖患者低氧血症（hypoxemia）发生率的影响。本研究共纳入264例患者，随机分为瑞马唑仑+艾司氯胺酮（esketamine）组（R组）与丙泊酚+艾司氯胺酮组（P组）：P组采用丙泊酚联合艾司氯胺酮实施麻醉，R组采用瑞马唑仑联合艾司氯胺酮实施麻醉。本研究的主要结局指标为低氧血症发生率；次要结局指标包括意识丧失（Loss of Consciousness, LoC）时间、苏醒时间，以及术中与术后不良反应发生率。

研究结果显示：R组轻度低氧血症发生率与P组相近（14.2% vs. 11.5%，p=0.396）；R组重度低氧血症发生率显著低于P组（4.2% vs. 9.2%，p=0.019）。R组意识丧失时间长于P组[中位数（四分位间距，interquartile range, IQR）：53s（45~61）vs. 50s（42~54），p=0.001]；R组麻醉苏醒时间短于P组[中位数（IQR）：48min（41~58）vs. 55.5min（46~67），p<0.001]。两组不良事件发生率无显著差异（所有指标p>0.05）。

综上，与丙泊酚联合艾司氯胺酮相比，瑞马唑仑联合艾司氯胺酮可降低肥胖患者行胃肠内镜检查时的重度低氧血症发生率。

临床试验注册：www.chictr.org.cn，注册号：ChiCTR2200065575。