Automated Control of End-tidal Volatile Anesthetic Concentration Using the MIRUS System: A Comparison of Isoflurane, Sevoflurane and Desflurane in Anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 主要终点
- volatile anaesthetics (VA) consumption
研究概览
简要总结
The new MIRUS system as well as the established AnaConDa system uses a reflector to conserve volatile anaesthetics (VA). Both systems act with commercially available ICU ventilators. In contrast to AnaConDa the MIRUS includes an automated control of end-tidal VA concentrations. In this study the investigators compared feasibility, costs and recovery times after anaesthesia with isoflurane (ISO), sevoflurane (SEVO) or desflurane (DES) in ventilated and spontaneously breathing patients.
详细描述
The study was approved by the appropriate Institutional Review Board. After written informed consent 63 ASA I-III patients undergoing elective hip or knee replacement surgery under general anesthesia were included. Patients were randomly organized into 3 groups (20-22 each). Anesthesia was induced with intravenous anaesthetics. After tracheal intubation MIRUS automatically adjusted the end-tidal VA concentration to 1.0 MAC. Patients were ventilated with the Puritan Bennett 840 ICU ventilator. After 1 h of anaesthesia with 1.0 MAC the ventilator mode was switched from SIMV V+ (totally controlled ventilation, "passive patient", with a tidal volume of 8 ml/IBW) to proportional assist ventilation (PAV) with 50% support ("active patient"). At the end of surgery the MIRUS system was stopped (MAC set to 0.0) and recovery times were measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing of the informed consent document (patient or relatives).
- •Patient age 18 years or older.
- •ASA I-III
排除标准
- •ASA IV patients
- •Epidural or spinal analgesia
- •Allergy or known hypersensitivity to any of the study drugs
- •Patients with known or suspected genetic susceptibility to malignant hyperthermia
- •Previous participation in this trial
- •Participation in another clinical trial within 4 weeks prior to selection.
- •Pregnant women
研究组 & 干预措施
Desflurane
Desflurane 5.0-6.0 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
干预措施: Desflurane (Drug)
Sevoflurane
Sevoflurane 1.4-2.1 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
干预措施: Sevoflurane (Drug)
Isoflurane
Isoflurane 0.9-1.2 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
干预措施: Isoflurane (Drug)
结局指标
主要结局
volatile anaesthetics (VA) consumption
时间窗: duration of anesthesia: max. 3 h
次要结局
- recovery times(duration post anesthesia care: max. 8 h after anesthesia)
研究者
Martin Bellgardt
Dr. med.
Ruhr University of Bochum