Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, No. 119, Southwest 4Th Ring RD, Fengtai District, Beijing, 100070, PR , China.
Department of Anesthesiology, DaxingDistrict, Beijing Daxing People's Hospital, No. 26, Huangcun West Street, Beijing, People's Republic of China.
BMC Anesthesiol. 2023 Mar 28;23(1):93. doi: 10.1186/s12871-023-02053-9.
Butorphanol slightly influences the respiratory and circulatory systems, has a better effect on relieving the discomfort caused by mechanical traction, and has a low incidence of postoperative nausea and vomiting (PONV). Combined butorphanol and propofol may suppress postoperative visceral pain, which is avoidable in gastrointestinal endoscopy. Thus, we hypothesized that butorphanol could decrease the incidence of postoperative visceral pain in patients undergoing gastroscopy and colonoscopy.
This was a randomized, placebo-controlled, and double-blinded trial. Patients undergoing gastrointestinal endoscopy were randomized to intravenously receive either butorphanol (Group I) or normal saline (Group II). The primary outcome was visceral pain after the procedure 10 min after recovery. The secondary outcomes included the rate of safety outcomes and adverse events. Postoperative visceral pain was defined as a visual analog scale (VAS) score ≥ 1.
A total of 206 patients were enrolled in the trial. Ultimately, 203 patients were randomly assigned to Group I (n = 102) or Group II (n = 101). In total, 194 patients were included in the analysis: 95 in Group I and 99 in Group II. The incidence of visceral pain at 10 min after recovery was found to be statistically lower with butorphanol than with the placebo (31.5% vs. 68.5%, respectively; RR: 2.738, 95% CI [1.409-5.319], P = 0.002), and the notable difference was in pain level or distribution of visceral pain (P = 0.006).
The trial indicated that adding butorphanol to propofol results in a lower incidence of visceral pain after surgery without noticeable fluctuations in circulatory and respiratory functions for gastrointestinal endoscopy patients.
Clinicaltrials.gov NCT04477733 (PI: Ruquan Han; date of registration: 20/07/2020).
布托啡诺对呼吸和循环系统有轻微影响，在缓解机械牵引引起的不适方面效果较好，术后恶心和呕吐（PONV）发生率较低。布托啡诺和丙泊酚联合使用可能抑制胃肠内镜术后内脏痛，这在胃肠内镜中是可以避免的。因此，我们假设布托啡诺可以降低接受胃肠内镜检查患者术后内脏痛的发生率。
这是一项随机、安慰剂对照、双盲试验。接受胃肠内镜检查的患者被随机静脉注射布托啡诺（I 组）或生理盐水（II 组）。主要结局为术后 10 分钟恢复时的内脏痛。次要结局包括安全性结局和不良事件的发生率。术后内脏痛定义为视觉模拟评分（VAS）评分≥1。
共有 206 名患者入组该试验。最终，203 名患者被随机分为 I 组（n=102）或 II 组（n=101）。共有 194 名患者纳入分析：I 组 95 名，II 组 99 名。恢复后 10 分钟时，布托啡诺组的内脏痛发生率明显低于安慰剂组（分别为 31.5%和 68.5%；RR：2.738，95%CI[1.409-5.319]，P=0.002），差异主要在疼痛程度或内脏痛的分布方面（P=0.006）。
该试验表明，在胃肠内镜患者中，与丙泊酚合用布托啡诺可降低术后内脏痛的发生率，且对循环和呼吸功能无明显波动。
Clinicaltrials.gov NCT04477733（PI：韩如权；注册日期：2020 年 7 月 20 日）。
