A Randomized Clinical Trial on the Efficiency, Hemodynamic Effects and Patient Comfort of Two Different Preparations of Sevoflurane After Vital Capacity Rapid Inhalation Induction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- effect of different preparations of sevoflurane on Induction on hypnosis time
研究概览
简要总结
In our study we aim to study the effects of two preparations of Sevoflurane in vital capacity rapid inhalation induction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing abdominal surgery
排除标准
- •Patients with any cardiovascular or respiratory disease, usage of any kind of sedative drug, expected airway difficulty and obese patients (BMI>35) will be excluded from the study
研究组 & 干预措施
Sevoflurane A
Generic sevoflurane
干预措施: Sevoflurane (Drug)
Sevoflurane B
Orginal sevoflurane
干预措施: Sevoflurane (Drug)
结局指标
主要结局
effect of different preparations of sevoflurane on Induction on hypnosis time
时间窗: 1 hour
Induction for anesthesia will be achieved with sevoflurane A and Sevoflurane B in total of 100 randomized (American Society of Anesthesiology status I-II) patients undergoing abdominal surgery. During the induction patients will be asked to breath as deep as possible and then hold their breaths to the point where they cannot anymore and flexing their right arm. Occurrence of hypnosis will be confirmed with both the loss of eyelash-reflex and failing of flexed-holding arm. Time and number of breaths needed for the loss of consciousness will be noted. Existence of hiccup, cough, increase in secretions, and refusal of the mask by the patient will be reported if any. All patients will be extubated and released to the ward after they are questioned about any discomfort or issue they want to report to anesthesiologist
次要结局
- effect of different sevoflurane preparations on hemodynamics(1 hour)
研究者
Guniz M.Koksal
Assoc.Prof
Istanbul University