Department of Anesthesiology and Critical Care, Command Hospital (Eastern Command), Alipore, India.
Indian J Pharmacol. 2013 Jan-Feb;45(1):24-9. doi: 10.4103/0253-7613.106430.
Incidence of postoperative nausea and vomiting (PONV), without active intervention, following laparoscopic cholecystectomy is unacceptably high. We evaluated the effectiveness of intravenous (IV) palonosetron in counteracting PONV during the first 24 hrs following laparoscopic cholecystectomy, using ondansetron as the comparator drug.
In a randomized, controlled, single blind, parallel group trial, single pre-induction IV doses of palonosetron (75 mcg) or ondansetron (4 mg) were administered to adult patients of either sex undergoing elective laparoscopic cholecystectomy. There were 49 subjects per group. The pre-anesthetic regimen, anesthesia procedure and laparoscopic technique were uniform. The primary effectiveness measure was total number of PONV episodes in the 24 hrs period following end of surgery. The frequencies of individual nausea, retching and vomiting episodes, visual analog scale (VAS) score for nausea at 2, 6 and 24 hrs, use of rescue antiemetic (metoclopramide), number of complete responders (no PONV or use of rescue in 24 hrs) and adverse events were secondary measures.
There was no statistically significant difference between the groups in primary outcome. Similarly, the frequencies of nausea, retching and vomiting episodes, when considered individually, did not show significant difference. Nausea score was comparable at all time points. With palonosetron, 14 subjects (28.6%) required rescue medication while 13 (26.5%) did so with ondansetron. The number of complete responders was 14 (28.6%) and 16 (32.7%), respectively. Adverse events were few and mild. QTc prolongation was not encountered.
Palonosetron is comparable to ondansetron for PONV prophylaxis in elective laparoscopic cholecystectomy when administered as single pre-induction dose.
在接受腹腔镜胆囊切除术的患者中，如果不进行积极干预，术后恶心和呕吐（PONV）的发生率高得令人无法接受。我们评估了静脉内（IV）帕洛诺司琼在对抗腹腔镜胆囊切除术后 24 小时内 PONV 的有效性，将昂丹司琼作为对照药物。
在一项随机、对照、单盲、平行组试验中，对接受择期腹腔镜胆囊切除术的成年男女患者，单次诱导前静脉给予帕洛诺司琼（75 mcg）或昂丹司琼（4 mg）。每组 49 例患者。术前方案、麻醉程序和腹腔镜技术都是统一的。主要有效性测量指标是手术后 24 小时内 PONV 发作的总次数。单个恶心、呕吐发作的频率、2、6 和 24 小时时的视觉模拟量表（VAS）评分、止吐补救治疗（甲氧氯普胺）的使用、完全缓解者（24 小时内无 PONV 或使用补救治疗）的数量和不良反应为次要措施。
两组在主要结局上无统计学差异。同样，当单独考虑时，恶心、呕吐发作的频率也没有显著差异。在所有时间点，恶心评分均相似。使用帕洛诺司琼，14 名受试者（28.6%）需要补救药物，而使用昂丹司琼的则有 13 名（26.5%）。完全缓解者的数量分别为 14 名（28.6%）和 16 名（32.7%）。不良反应较少且轻微。未出现 QTc 延长。
在择期腹腔镜胆囊切除术中，单次诱导前给予帕洛诺司琼与昂丹司琼预防 PONV 相当。
