Dexamethasone Alone Versus in Combination With Intra-operative Super-hydration for Prevention of Postoperative Nausea and Vomiting in Female Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative Nausea and Vomiting (PONV)
研究概览
简要总结
Postoperative nausea and vomiting (PONV) are the most common and distressing side effects following Laparoscopic cholecystectomy
详细描述
In the operating room, standard monitors included electrocardiogram, noninvasive arterial blood pressure, arterial oxygen saturation, and end-tidal carbon dioxide were connected. All patients received standardized anesthetic technique. At the end of surgery, gastric contents were suctioned via an orogastric tube before extubation. Atropine and neostigmine (1/2.5 mg) was given slowly I.V. to antagonize the residual neuromuscular block. Then, the trachea was extubated. Then, patients were transferred to the post-anesthesia care unit in a stable condition. Patients were allowed to drink liquids as soon as requested.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I or II aged Elective laparoscopic cholecystectomy
排除标准
- •Steroids use within the last 3 days before surgery Antiemetic use within the last 3 days before surgery Opioids use within the last 3 days before surgery. Patients with liver, cardiac or renal diseases Patients with Pregnancy Patients with Bmi ˃ 30kg/m2 Patients with Delayed wound healing Open surgery
研究组 & 干预措施
Dexamethasone Group
I.V. Dexamethasone 5 mg just before induction plus intra-operative 10 ml/kg Ringer's lactate solution.
干预措施: Dexamethasone (Drug)
Dexamethasone Group
I.V. Dexamethasone 5 mg just before induction plus intra-operative 10 ml/kg Ringer's lactate solution.
干预措施: 10 ml/kg Ringer's lactate (Drug)
Dexamethasone and super-hydration Group
I.V. Dexamethasone 5 mg just before induction of anesthesia plus intraoperative 30 ml/kg Ringer's lactate solution
干预措施: Dexamethasone (Drug)
Dexamethasone and super-hydration Group
I.V. Dexamethasone 5 mg just before induction of anesthesia plus intraoperative 30 ml/kg Ringer's lactate solution
干预措施: 30 ml/kg Ringer's lactate (Drug)
结局指标
主要结局
Postoperative Nausea and Vomiting (PONV)
时间窗: Within the first 24 hours postoperatively
A nurse, who was unaware about the groups to which the patient belonged, evaluated patients at 0, 6, and 24 h after surgery for any symptoms of nausea, retching, or vomiting. PONV is classified as early, if occurring up to 6h after surgery, or late, if occurring between 6 h up to 24 postoperatively. A Verbal Descriptive Scale (VDS), was used to assess the severity of PONV: no PONV (grade 0), mild PONV (grade 1), moderate PONV (grade 2) and severe PONV (grade 3)
次要结局
- Antiemetic usage(Within the first 24 hours postoperatively)
- Total analgesic consumption(Within the first 24 hours postoperatively)
- Pain Score(Within the first 24 hours postoperatively)
- Incidence of delayed wound healing(Within the first week postoperatively)
- Total number of patients who had nausea, vomiting or retching(Within the first 24 hours postoperatively)
- Incidence of wound infection(Within the first week postoperatively)
研究者
Sayed Kaoud Abd-Elshafy
Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University
Assiut University