Metoclopramide-Ondansetron Dual Therapy vs Metoclopramide Monotherapy for Treatment of Nausea and Vomiting Post Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- postoperative nausea and vomiting
研究概览
简要总结
The incidence of postoperative nausea and vomiting (PONV) after general anesthesia is up to 30% when inhalational anesthetics are used with no prophylaxis. This makes PONV one of the most common complaints following surgery under general anesthesia, together with postoperative pain.
详细描述
This is a prospective, randomized, double-blind controlled clinical trial. Written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 equal groups:
Group 1: Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia.
Group 2: Patients will receive 10 mg metoclopramide before induction of general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aging 16 years and above
- •Patients undergoing laparoscopic cholecystectomy under General Anesthesia at Makassed General Hospital
排除标准
- •Patients with history of motion sickness
- •Patients on previous treatment by anti-emetics for dizziness, vertigo or other causes of nausea and vomiting
- •Patients with any type of allergy to metoclopramide or ondansetron
- •Patients refusing to be part of the study (refusal to sign consent)
- •Patients on previous treatment by opioids
研究组 & 干预措施
Dual therapy
Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia
干预措施: Dual therapy (Other)
Dual therapy
Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia
干预措施: General anesthesia (Other)
Monotherapy
Patients will receive 10 mg metoclopramide before induction of general anesthesia.
干预措施: Monotherapy (Other)
Monotherapy
Patients will receive 10 mg metoclopramide before induction of general anesthesia.
干预措施: General anesthesia (Other)
结局指标
主要结局
postoperative nausea and vomiting
时间窗: 36 hours postoperatively
The Primary aim of this study is to compare the effect of prophylactic combination therapy (dual therapy) metoclopramide-ondansetron vs. ondansetron monotherapy for the treatment of postoperative nausea and vomiting after laparoscopic cholecystectomy. This will be assessed through a questionnaire with yes or no question where yes indicates the presence of nausea or vomiting and no indicating the absence of nausea or vomiting.
次要结局
- Surgeon satisfaction(36 hours postoperatively)
- Patient satisfaction(36 hours postoperatively)
研究者
Zoher Naja
Chairperson of Anesthesia and Pain Management Department
Makassed General Hospital