Impact of Pyloric Injection With Magnesium Sulphate and Lidocaine Mixture on Early Postoperative Outcome After Laparoscopic Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Postoperative nausea and vomiting
研究概览
简要总结
Postoperative nausea and vomiting is a common adverse effect after sleeve gastrectomy, mostly due to increased intragastric pressure. The present trial aimed to assess the effect of pyloric injection of mixture of magnesium sulfate and lidocaine on postoperative gastric intraluminal pressure and incidence of nausea and vomiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that aged between18 and 65 years.
- •American Society of Anesthesiologists (ASA) class I - III.
- •Morbidly-obese patients who failed to achieve and maintain a clinically significant weight loss through supervised non-surgical methods for at least 6 months.
- •Surgery was conducted as the first line of treatment in case of patients with BMI ≥ 50 kg/m2 (super obese).
排除标准
- •Obesity secondary to endocrine disorders.
- •History of any previous bariatric procedure.
- •Impaired intellectual capacity or major psyciatric disorder.
- •Sweet eaters who would not adopt a change of postoperative eating habits.
- •Lack of willingness and motivation to embrace postoperative lifestyle changes.
- •Substance abuse.
- •Pregnancy or expected pregnancy in the following 12 to 18 months.
- •Severe gastroesophageal reflux disease
研究组 & 干预措施
Pyloric injection of magnesium sulfate and lidocaine mixture
After sleeve gastrectomy, the pylorus is injected with a mixture of magnesium sulfate and lidocaine
干预措施: Pyloric injection of magnesium sulfate and lidocaine mixture (Procedure)
Pyloric injection of saline
After sleeve gastrectomy, the pylorus is injected with normal saline
干预措施: Pyloric injection of saline (Procedure)
结局指标
主要结局
Postoperative nausea and vomiting
时间窗: first 24 hours after surgery
incidence of postoperative nausea and vomiting as measured by special impact scale
次要结局
未报告次要终点
研究者
Sameh Emile
Lecturer of general surgery
Mansoura University