咪达唑仑联合丙泊酚或阿片类药物镇静对结肠镜检术后恢复质量的影响：随机临床试验
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咪达唑仑联合丙泊酚或阿片类药物镇静对结肠镜检术后恢复质量的影响：随机临床试验
翻译：任文鑫 编辑：冯玉蓉 审校：曹莹
背景：人们担忧咪达唑仑用于结肠镜检查复合镇静，可能会损害认知功能并延长恢复时间。我们的目的是明确咪达唑仑是否对包括认知功能在内的多维度的恢复产生短期和长期影响。
方法：本项双中心、双盲、安慰剂对照、平行分组、随机、1:1分配比例的IV期研究，研究对象为接受择期门诊结肠镜检查的18岁以上成年人，其英语水平足以完成术后恢复质量量表（PostopQRS）。受试者在使用丙泊酚镇静前给予咪达唑仑(0.04mg.kg−1)或等体积的0.9%生理盐水，加或不加阿片类制剂。主要观察指标是结肠镜检查后第3天PostopQRS认知功能的恢复率，采用χ2检验进行分析。次要指标包括随着时间推移PostopQRS其他功能的恢复情况、睁眼时间、住院时间以及患者和内窥镜医生的满意度。所有假设均在招募之前定义。
结果：在2015年9月至2018年6月期间，406名患者被分配至咪达唑仑组(n=201)或安慰剂组(n=205)，其中一名患者在分配前退出研究。结肠镜检查后第3天PostopQRS认知功能恢复无显著差异(咪达唑仑86.8% vs安慰剂88.7%，优势比0.838；95%CI 0.42~1.683；P=.625)。此外，随着时间推移，PostopQRS认知功能的恢复没有差异（P=0.534）。PostopQRS总体恢复情况随着时间的推移而增加，但组间没有差异。此外，在PostopQRS伤害性感受、情绪和日常生活活动方面，各组之间没有差异。患者和内窥镜医生的满意度都很高，没有差异。两组患者睁眼时间(咪达唑仑9.4±12.8min vs安慰剂组7.3±0.7min；P=.055)或出院时间(咪达唑仑103.4±1.4min vs安慰剂组98.4±37.0min；P=.516)均无差异。
结论：在择期结肠镜检查中加用咪达唑仑0.04 mg·kg-1作为丙泊酚和阿片类镇静剂的辅助用药，在PostopQRS的认知功能、恢复质量、苏醒时间和出院时间等方面均无明显差异。咪达唑仑的使用应由麻醉医生决定。
原始文献来源：Usha Gurunathan, Tony Rahman, Zelda Williams, et al. Effect of Midazolam in Addition to Propofol and Opiate Sedation on the Quality of Recovery After Colonoscopy: A Randomized Clinical Trial.Anesth Analg 2020;131:741–50.
Effect of Midazolam in Addition to Propofol and Opiate Sedation on the Quality of Recovery After Colonoscopy: A Randomized Clinical Trial
BACKGROUND: There is a concern that midazolam, when used as a component of sedation for colonoscopy, may impair cognition and prolong recovery. We aimed to identify whether midazolam produced short- and longer-term effects on multiple dimensions of recovery including cognition.
METHODS: A 2-center double-blinded, placebo-controlled, parallel-group, randomized, phase IV study with a 1:1 allocation ratio was conducted in adults ≥18 years of age undergoing elective outpatient colonoscopy, with sufficient English language proficiency to complete the Postoperative Quality of Recovery Scale (PostopQRS). Participants were administered either midazolam (0.04 mg·kg−1) or an equivalent volume of 0.9% saline before sedation with propofol with or without an opiate. The primary outcome was incidence of recovery in the cognitive domain of the PostopQRS on day 3 after colonoscopy, which was analyzed using a χ2 test. Secondary outcomes included recovery in other domains of the PostopQRS over time, time to eye-opening, and hospital stay, and patient and endoscopist satisfaction. All hypotheses were defined before recruitment.
RESULTS: During September 2015 to June 2018, 406 patients were allocated to either midazolam (n = 201) or placebo (n = 205), with one withdrawn before allocation. There was no significant difference in recovery in the cognitive domain of the PostopQRS on day 3 after colonoscopy (midazolam 86.8% vs placebo 88.7%, odds ratio, 0.838; 95% confidence interval [CI], 0.42–1.683; P = .625). Furthermore, there was no difference in recovery over time in the cognitive domain of the PostopQRS (P = .534). Overall recovery of the PostopQRS increased over time but was not different between groups. Furthermore, there were no differences between groups for nociceptive, emotive, activities-of-daily-living domains of the PostopQRS. Patient and endoscopist satisfaction were high and not different. There were no differences in time to eye-opening (midazolam 9.4 ±12.8 minutes vs placebo 7.3 ± 0.7 minutes; P = .055), or time to hospital discharge (midazolam 103.4 ± 1.4 minutes vs placebo 98.4 ± 37.0 minutes; P = .516).
CONCLUSIONS: The addition of midazolam 0.04 mg·kg−1 as adjunct to propofol and opiate sedation for elective colonoscopy did not show evidence of any significant differences in recovery in the cognitive domain of the PostopQRS, overall quality of recovery as measured by the PostopQRS, or emergence and hospital discharge times. The use of midazolam should be determined by the anesthesiologist.
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