Comparison of intravenous amisulpride and ondansetron for prevention of postoperative nausea and vomiting after gynaecological laparoscopy: a randomized clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Incidence and severity of nausea and vomiting
研究概览
简要总结
Postoperative nausea and vomiting are common and problematic after general anesthesia in laparoscopic surgery. The incidence of PONV in gynecological surgery occurs at a rate of 40 to 75% even as high as 90%. PONV is associated with female gender, previous PONV, motion sickness, smoke free status and opioid use. The use of intravenous amisulpride for prevention of PONV in gynecological laparoscopic surgeries has not been explored. Amisulpride is a selective antagonist of dopamine D2 and D3 receptors. Therefore, the present study aimed to probe and investigate the effectiveness of intravenous amisulpride and ondansetron for prevention of PONV in laparoscopic surgery. All selected patients will be randomized in to two groups (40 patients in each group) depending on the drug used.
Group A- received intravenous amisulpride 5 mg diluted with 5 ml normal saline at the time of induction of anesthesia slowly over 2 minutes.
Group O - received intravenous ondansetron 4 mg diluted with 5 ml normal saline at the time of induction of anesthesia slowly over 2 minutes.
Primary outcome is incidence and severity of PONV experienced by each patient after surgery and recorded at following three assessment periods: 0-2 hr, 2-6 hr and 6-24 hr after surgery.
Secondary outcome is requirement of rescue antiemetic at same time interval and patient satisfaction score after 24 hr after surgery.
Statistical analysis will be done after completion of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA Grade I and II Scheduled for laparoscopic surgery under general anesthesia.
排除标准
- •Allergy to any drug involved in the study History of other antiemetic drug usage and motion sickness Morbid obesity Emergency surgery History of alcohol opioid and drug abuse Psychiatric and pregnant patients.
结局指标
主要结局
Incidence and severity of nausea and vomiting
时间窗: assessment periods: 0–2 hr, 2–6 hr and 6–24 h after surgery.
次要结局
- Requirement of rescue antiemetic and patients satisfaction score(Assessment periods: 0–2 hr, 2–6 hr and 6–24 h after surgery.)
研究者
DR VELLORE SRIKANTH HAMSA
Apollo Hospitals Bilaspur