Effect of Preoperative Mannitol Infusion on Cerebral Oxygen Saturation and Patients' Recovery After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- rSO2
研究概览
简要总结
Decreased cerebral oxygen saturation (rSO2) was reported to occur during insufflation for laparoscopic procedures due to increased Intracranial pressure (ICP) with resultant decrease in cerebral perfusion pressure.
详细描述
Forty patients scheduled for laparoscopic cholecystectomy will be enrolled in this double blind, randomized controlled study. Patients will receive either 0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia (group M) or an equal volume of 0.9% normal saline instead (group C). Primary outcome measure is rSO2. Secondary outcome variables include extubation time, clinical assessment of consciousness recovery using the modified Observer's assessment of alertness/sedation scale (OAA/S) and the mini-mental state examination (MMSE) for cognitive evaluation after recovery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status I or II
- •aged between 25 and 50 years
- •with a body mass index (BMI) 22-34 kg/m2
排除标准
- •obstructive or restrictive pulmonary disease
- •cardiac dysfunction
研究组 & 干预措施
Mannitol
Patients will receive 0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia
干预措施: Mannitol (Drug)
Control
Patients will receive normal saline
干预措施: Control (Drug)
结局指标
主要结局
rSO2
时间窗: participants will be followed for the duration of surgery, an expected average of 1 hour
次要结局
- extubation time(intraoperative)
研究者
Hany A. Mowafi
Associate professor
Imam Abdulrahman Bin Faisal University