Levin David Neville, Dulberg Zachary, Chan An-Wen, Hare Gregory M T, Mazer C David, Hong Aaron
Department of Anesthesia, Keenan Research Centre for Biomedical Science and Li Ka Shing Knowledge Institute of St. Michael's Hospital, University of Toronto, Toronto, ON, Canada.
Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
Can J Anaesth. 2017 Apr;64(4):385-395. doi: 10.1007/s12630-017-0814-3. Epub 2017 Feb 3.
Nabilone is a synthetic cannabinoid with properties that make it an appealing candidate as a postoperative nausea and vomiting (PONV) prophylactic adjunct. Nabilone has proven clinical utility in chemotherapy-related nausea and vomiting but has not been adequately tested for PONV. The purpose of this study was to evaluate the effectiveness of a single dose of nabilone for the prevention of PONV.
This was a pragmatic single-centre randomized-controlled trial comparing oral nabilone vs placebo for the prevention of PONV. Eligible patients scheduled for elective surgery under general anesthesia who had a preoperative risk of PONV greater than 60% received either nabilone 0.5 mg or placebo orally prior to surgery. As part of the pragmatic design, the study medication was given in addition to any other combination of antiemetic prophylaxis. The primary outcome was the incidence of PONV. Secondary outcomes included the effect on pain, speed of recovery, and drug side effects.
Of the 340 patients randomized, 172 received nabilone and 168 received placebo. There was no difference in the incidence of PONV, which occurred in 20.9% in the nabilone group and 21.4% in the placebo group (relative risk, 0.98; 95% confidence interval, 0.89 to 1.11; P = 0.99). There were also no differences in pain scores, opioid consumption, or reported drug side effects.
Oral nabilone 0.5 mg given as a single dose prior to surgery is ineffective in reducing PONV. This trial was registered at ClinicalTrials.gov, identifier: NCT02115529.
纳布啡是一种合成大麻素，其特性使其成为术后恶心呕吐（PONV）预防性辅助用药的有吸引力的候选药物。纳布啡在化疗相关恶心呕吐方面已证明具有临床效用，但尚未针对PONV进行充分测试。本研究的目的是评估单剂量纳布啡预防PONV的有效性。
这是一项务实的单中心随机对照试验，比较口服纳布啡与安慰剂预防PONV的效果。计划在全身麻醉下进行择期手术且术前PONV风险大于60%的符合条件患者，在手术前口服0.5毫克纳布啡或安慰剂。作为务实设计的一部分，研究药物是在任何其他止吐预防措施组合之外给予的。主要结局是PONV的发生率。次要结局包括对疼痛、恢复速度和药物副作用的影响。
在340例随机分组的患者中，172例接受纳布啡，168例接受安慰剂。PONV的发生率没有差异，纳布啡组为20.9%，安慰剂组为21.4%（相对风险，0.98；95%置信区间，0.89至1.11；P = 0.99）。疼痛评分、阿片类药物消耗量或报告的药物副作用也没有差异。
术前单剂量口服0.5毫克纳布啡在降低PONV方面无效。该试验已在ClinicalTrials.gov注册，标识符：NCT02115529。
