Optimal Dosing of Preoperative Gabapentin for Prevention of Postoperative Nausea and Vomiting After Abdominal Laparoscopic Surgery: a Randomized Prospective Comparative Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Severity of nausea
研究概览
简要总结
Overall incidence of postoperative nausea and vomiting (PONV) after general anesthesia is 40-90 % . gabapentin has been incorporated into "fast-track" packages and improved recovery during surgery protocols to avoid unintended side effects associated with opioid alternatives. Interestingly, gabapentin has also been noted to reduce the effects of chemotherapy-induced nausea, effective in treatment of gravidarum hyperemesis, and postdural puncture emesis. Different dosing regimens were tested.The goal of the study is to determine the most effective dose of oral gabapentin given 1 hour prior to surgery on the occurrence and severity of PONV and drug side effects in the first 24 hours postoperatively to find the most effective dose of gabapentin with the least side effects.
详细描述
A total of (150) adult patients who will undergo elective abdominal laparoscopic surgery will be included in the study. Written informed consent will be obtained from all patients before randomization. Randomization will be done with the help of a computer generated list of numbers. Patients will be divided randomly and equally into three groups (50 patients each(. The first group of patients will receive 300 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G1), the second group of patients will receive 600 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G2), the third group of patients will receive 900 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water (group G3). Drug formulation will be done by one of the researchers making the dosage of the three groups the same in number and shape of the capsules and then given to a junior anesthetist who is neither involved nor interested in any way in the sample to be administered to the patients surveyed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Drug formulation will be done by one of the researchers making the dosage of the three groups the same in number and shape of the capsules and then given to a junior anesthetist who is neither involved nor interested in any way in the sample to be administered to the patients surveyed. Blind grouping will be kept to all including the patients themselves, until the completion of the study. Data collection will be done by another anesthesiologist who is blinded to the given medication during the study and not included in the research team.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between (18- 65) years
- •scheduled for elective laparoscopic abdominal surgery.
排除标准
- •age below 18 and above 60 years
- •ASA III- IV
- •pregnancy or breastfeeding
- •psychiatric illness
- •administration of antiemetic or systemic corticosteroids within 24 hours prior to surgery
- •vomiting within 24 hours prior to surgery
- •alcohol or drug abuse;
- •known hypersensitivity or contraindications to gabapentin
- •impaired liver or kidney function
- •history of motion sickness
- •patients on anti-depressants
- •patients on whom laparoscopic procedure converted into open technique.
研究组 & 干预措施
G 300
The patients will receive 300 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water
干预措施: Gabapentin (Drug)
G 600
The patients will receive 600 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water
干预措施: Gabapentin (Drug)
G 900
The patients will receive 900 mg gabapentin orally 1 hour before induction of anesthesia by a sip of water
干预措施: Gabapentin (Drug)
结局指标
主要结局
Severity of nausea
时间窗: at H24 (24th hour) postoperative
measured by nausea verbal numerical rating scale (NVRS) which is an eleven points scale describing nausea severity (0= no nausea, 10= worst nausea imaginable, mild nausea 1-3, moderate 4-6, or severe 7-10)
Incidence of PONV episodes (nausea, retching or vomiting)
时间窗: at H24 (24th hour) postoperative
number of attacks
次要结局
- Need for rescue antiemetic(during the first 24 hours postoperative)
- incidence of side effects(during the first 24 hours postoperative)
- Intensity of postoperative pain: Visual Analogue Scale(Total dose in (mg) given during the first 24 hours postoperative)
研究者
Tamer Nabil Abdelrahman
Lecturer of anesthesia, Intensive care and pain management
Ain Shams University