The Effect of Preoperative Anxiolysis With Intravenous Midazolam on Intraoperative Sevoflurane Gas Consumption: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Sevoflurane consumption
研究概览
简要总结
This prospective, randomized, double-blind, placebo-controlled study is performed after obtaining written informed consent of patients who are scheduled for elective general surgery. After the admission to the preoperative unit 30 minutes before the surgery, The preoperative anxiety of patients is evaluated by The State-Trait Anxiety Inventory (STAI). Patients are randomly assigned to one of two groups in a 1:1 ratio by a computer-generated list. Patients receive midazolam IV at 0.04 mg/kg (group M) and an equal volume of saline IV (group C, control group). Anesthesia is induced with 2mg/kg of IV propofol. At a dose of 0.6 mg/kg, IV rocuronium bromide is given for neuromuscular blockade. Anesthesia is maintained at 2% sevoflurane. At the end of the surgery, anesthesia is terminated and the awake patients are extubated.
详细描述
An equal depth of anesthesia is achieved by evaluating an entropy value of 40-50 during the operation. Heart rate, blood pressure, the amount of sevoflurane consumed (ml), end-tidal sevoflurane concentration (%), sevoflurane MAC, inspiratory sevoflurane (%) are recorded at baseline and 15-minute intervals.
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
- 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
- 否
入选标准
- •American Society of Anesthesiologists physical status 1 and 2
- •patients who are scheduled for elective surgery
排除标准
- •history of psychiatric disease
- •use of psychotropic medications
- •neurological disorders
- •chronic pain
- •cardiovascular, respiratory, and hepatic diseases.
研究组 & 干预措施
Group M
Patients receive midazolam IV at 0.04 mg/kg (group M).
干预措施: Midazolam (Drug)
Group C
Patients receive an equal volume of saline IV (group C, control group).
干预措施: Saline (Other)
结局指标
主要结局
Sevoflurane consumption
时间窗: 1 hour
The amount of sevoflurane consumed (ml)
次要结局
- end-tidal sevoflurane concentration (%)(1 hour)
研究者
Ersel GULEC
Principal Investigator
Cukurova University