Depth of Long Term ICU Sedation Under 0,5 MAC Isoflurane, Sevoflurane or Desflurane Using MIRUS, an Automated Delivery System for Volatile Anaesthetics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- usage of volatile anesthetics at 0.5 MAC during ICU Sedation
研究概览
简要总结
The MIRUS system (TIM, Andernach, Germany) as well as the AnaConDa uses a reflector to conserve volatile anaesthetics (VA). Both systems can be paired with ICU ventilators, but MIRUS features an automated control of end-tidal VA concentrations (etVA). We compare depth of 0.5 MAC inhalational long-term sedation with Isoflurane (ISO), Sevoflurane (SEVO) or Desflurane (DES).
详细描述
The study was approved by the appropriate Institutional Review Board. Thirty ASA II-IV patients, undergoing elective or emergency surgery under general anaesthesia were included and randomized into three equal groups: ISO, SEVO or DES. We used MIRUS, a gas delivery system with a VA reflector, just like AnaConDa, that can be paired with common ICU ventilators. Additionally, MIRUS features the unique ability to maintain the end-tidal concentration (etVA) in target by automatically adjusting the delivery rate. Every 8 hours, the RASS was assessed by the nurse. The log of the EEG-Narcotrend Index (NI) was also included in the study.
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
ISO
Drug name: Isoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (0.5 Vol%)
干预措施: Isoflurane (Drug)
SEVO
Drug name: Sevoflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (1.0 Vol%)
干预措施: Sevoflurane (Drug)
DES
Drug name: Desflurane Dosage form: inhalational Dosage: ml/h Concentration: 0.5 MAC (3.0 Vol%)
干预措施: Desflurane (Drug)
结局指标
主要结局
usage of volatile anesthetics at 0.5 MAC during ICU Sedation
时间窗: up to one week
Comparison between Isofluarne, Sevoflurane and Desflurane
次要结局
未报告次要终点
研究者
Martin Bellgardt
Prof. Dr. med. Thomas Weber, Director Anesthesiology department St. Josef-Hospitital
Ruhr University of Bochum