Study Effects of Preoperative Modafinil on Recovery Profile of Morbidly Obese Patients Scheduled for Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- both groups were assessed as regard incidence of enhancement of immediate and cognitive recovery Comparison between groups as regard words recall as part of cognitive recovery data.
研究概览
简要总结
study Effects of Preoperative Modafinil on Recovery Profile of Morbidly Obese Patients Scheduled for Bariatric Surgery if it Can Enhance Recovery From Anesthesia and provide improvement in recovery
详细描述
The study was conducted to 20 patients scheduled for bariatric surgeries. The study group (Modafinil group) received oral 200 mg modafinil 8 hours before surgery and then another 200 mg 2 hours before surgery. The other group (Placebo group) were given placebo through the same regimen as Modafinil. Immediate recovery time, cognitive recovery, emotional (general) status, discharge from PACU according to modified Aldrete score were assessed.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged from 18 to 60 years.
- •Patients ASA II or III undergoing elective bariatric surgery.
- •BMI 30-50 kg/m2.
排除标准
- •Patient's refusal.
- •Age below 18 or above 60y.
- •History of cardiac disease.
- •History or known allergy to Modafinil.
- •Underlying liver or renal failure.
- •Chronic neurological or psychiatric condition.
- •Hemodynamically unstable patients.
- •History of drug dependance.
- •Habitual coffee consumption exceeding 2 cups per day.
研究组 & 干预措施
10 patients received modafinil preoperatively
assessing enhancement of recovery from anesthesia
干预措施: Modafinil (Drug)
10 patients didnot receive modafinil preoperatively
干预措施: Modafinil (Drug)
结局指标
主要结局
both groups were assessed as regard incidence of enhancement of immediate and cognitive recovery Comparison between groups as regard words recall as part of cognitive recovery data.
时间窗: 1 day
Groups were compared in the primary outcome of our work (immediate recovery data) in OR by time intervals (T1, T2, T3 and T4) Comparison between groups as regard orientation as part of cognitive recovery score
次要结局
- assessment of difference of general and emotional status between both patients groups postoperatively(24 hours)
研究者
foad farouk mohamed
lecturer of anesthesia, ICU and pain management
Ain Shams University