Department of Anesthesiology, The Ohio State University Medical Center, Columbus, OH, USA; Department of Neurological Surgery, The Ohio State University Medical Center, Columbus, OH, USA.
Department of Anesthesiology, The Ohio State University Medical Center , Columbus, OH , USA.
Front Med (Lausanne). 2016 Feb 2;3:1. doi: 10.3389/fmed.2016.00001. eCollection 2016.
Postoperative nausea and vomiting (PONV) is a displeasing experience that distresses surgical patients during the first 24 h after a surgical procedure. The incidence of postoperative nausea occurs in about 50%, the incidence of postoperative vomiting is about 30%, and in high-risk patients, the PONV rate could be as high as 80%. Therefore, the study design of this single arm, non-randomized, pilot study assessed the efficacy and safety profile of a triple therapy combination with palonosetron, dexamethasone, and promethazine to prevent PONV in patients undergoing craniotomies under general anesthesia.
The research protocol was approved by the institutional review board and 40 subjects were provided written informed consent. At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV, and promethazine 25 mg IV was given as PONV prophylaxis. After surgery, subjects were transferred to the surgical intensive care unit or post anesthesia care unit as clinically indicated. Ondansetron 4 mg IV was administered as primary rescue medication to subjects with PONV symptoms. PONV was assessed and collected every 24 h for 5 days via direct interview and/or medical charts review.
The overall incidence of PONV during the first 24 h after surgery was 30% (n = 12). The incidence of nausea and emesis 24 h after surgery was 30% (n = 12) and 7.5% (n = 3), respectively. The mean time to first emetic episode, first rescue, and first significant nausea was 31.3 (±33.6), 15.1 (±25.8), and 21.1 (±25.4) hours, respectively. The overall incidence of nausea and vomiting after 24-120 h period after surgery was 30% (n = 12). The percentage of subjects without emesis episodes over 24-120 h postoperatively was 70% (n = 28). No subjects presented a prolonged QTc interval ≥500 ms before and/or after surgery.
Our data demonstrated that this triple therapy regimen may be an adequate alternative regimen for the treatment of PONV in patients undergoing neurological surgery under general anesthesia. More studies with a control group should be performed to demonstrate the efficacy of this regimen and that palonosetron is a low risk for QTc prolongation.
NCT02635828 (https://clinicaltrials.gov/show/NCT02635828).
术后恶心和呕吐（PONV）是一种令人不快的体验，会在手术后 24 小时内困扰手术患者。术后恶心的发生率约为 50%，呕吐的发生率约为 30%，在高危患者中，PONV 发生率可高达 80%。因此，这项单臂、非随机、初步研究的设计评估了三药联合预防全麻下颅脑手术患者 PONV 的疗效和安全性，三联疗法包括帕洛诺司琼、地塞米松和异丙嗪。
该研究方案经机构审查委员会批准，40 名受试者提供了书面知情同意书。在麻醉诱导时，给予三药联合预防方案：帕洛诺司琼 0.075mg IV、地塞米松 10mg IV 和异丙嗪 25mg IV。手术后，根据临床指征将受试者转移至外科重症监护病房或麻醉后恢复室。对于出现 PONV 症状的受试者，给予昂丹司琼 4mg IV 作为一线解救药物。通过直接访谈和/或病历回顾，在术后 5 天内每 24 小时评估和收集一次 PONV。
术后 24 小时内 PONV 的总发生率为 30%（n=12）。术后 24 小时恶心和呕吐的发生率分别为 30%（n=12）和 7.5%（n=3）。首次呕吐发作、首次解救和首次明显恶心的平均时间分别为 31.3（±33.6）、15.1（±25.8）和 21.1（±25.4）小时。术后 24-120 小时恶心和呕吐的总发生率为 30%（n=12）。术后 24-120 小时无呕吐发作的受试者比例为 70%（n=28）。手术前后无受试者出现 QTc 间期延长≥500ms。
我们的数据表明，这种三联疗法可能是全麻下神经外科手术患者治疗 PONV 的一种合适的替代方案。应该进行更多的对照研究来证明这种方案的疗效，以及帕洛诺司琼延长 QTc 间期的风险较低。
NCT02635828（https://clinicaltrials.gov/show/NCT02635828）。
