Ganjare Ashish, Kulkarni Atul P
Department of Anaesthesiology, Critical Care and Pain, Tata Memorial Hospital, Mumbai, Maharashtra, India.
Indian J Anaesth. 2013 Jan;57(1):41-5. doi: 10.4103/0019-5049.108560.
Postoperative nausea and vomiting (PONV) are common and distressing symptoms after surgery performed under general anaesthesia. 5-hydroxytryptamine3 antagonists are routinely used for prevention and treatment of PONV. The aim of our study was to compare the incidence of QTc prolongation and quantify the amount of QTc prolongation with ondansetron and granisetron.
This prospective, randomised, single-blind study was carried out in the OT and Recovery Room (RR) of a tertiary referral cancer centre. After obtaining Institutional Review Board approval and written informed consent from the patients, 70 patients undergoing elective surgery for carcinoma breast were included. In the RR, patients randomly received 8 mg of ondansetron or 1 mg of granisetron intravenously. Serial ECGs were recorded at various intervals, Non-invasive blood pressure and SpO2 were also recorded. Chi-square test and Mann-Whiteny test were used for statistical analysis.
The demographics were similar in both groups. The incidence of significant QTc prolongation was significantly higher in the ondansetron group (22 of 37 (59.4%) vs. 11 of 33 patients (33.33%) (P<0.05)). There was an increase in the QTc interval in both the groups as compared to the baseline. The median prolongation in QTc interval from baseline was much more in the ondansetron group; this was statistically significant only at 5 and 15 min.
Granisetron may be a safer option than ondanasetron for prevention and treatment of PONV due to lesser prolongation QTc interval. (ClinicalTrials.gov ID: NCT01352130).
术后恶心呕吐(PONV)是全身麻醉手术后常见且令人痛苦的症状。5-羟色胺3拮抗剂常用于预防和治疗PONV。我们研究的目的是比较昂丹司琼和格拉司琼导致QTc延长的发生率,并量化QTc延长的程度。
这项前瞻性、随机、单盲研究在一家三级转诊癌症中心的手术室和恢复室(RR)进行。在获得机构审查委员会批准并征得患者书面知情同意后,纳入70例行择期乳腺癌手术的患者。在恢复室,患者随机静脉注射8mg昂丹司琼或1mg格拉司琼。在不同时间间隔记录系列心电图,同时记录无创血压和脉搏血氧饱和度。采用卡方检验和曼-惠特尼检验进行统计分析。
两组的人口统计学特征相似。昂丹司琼组显著QTc延长的发生率显著高于格拉司琼组(37例中有22例(59.4%) vs. 33例中有11例(33.33%),P<0.05)。与基线相比,两组的QTc间期均有增加。昂丹司琼组QTc间期较基线的中位延长幅度更大;仅在5分钟和15分钟时具有统计学意义。
由于QTc间期延长较少,格拉司琼在预防和治疗PONV方面可能比昂丹司琼更安全。(ClinicalTrials.gov标识符:NCT01352130)