Postanaesthetic Outcome and Assessment of Fatigue in Day-surgery Laparoscopic Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Incidence and severity of fatigue after anaesthesia based on propofol or desflurane
研究概览
简要总结
The purpose of this study is to establish validated outcome measures for Postoperative Fatigue and Postoperative nausea, and to compare clinical impact of postanaesthetic symptoms during first week after Propofol or Desflurane based anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for day-surgery laparoscopic cholecystectomy
- •The patient is able to read and comprehend Norwegian language
- •The patient is cognitive adequate and able to fill in survey forms
- •The patient has read and signed patient information form
排除标准
- •Serious illness (ASA 3-4)
- •Pregnancy or suspected pregnancy
- •Breastfeeding women
- •Contraindications to use of NSAIDs
- •Serious allergic reaction to anaesthetics
- •Allergy towards egg, soya or peanuts
- •Known or suspected Malignant Hyperthermia or Porphyria
- •Fatigue-related diagnosis
- •Recently received adjuvant therapy (chemotherapy, radiotherapy)
- •Severe chronic pain
研究组 & 干预措施
Desflurane
Patients will receive Desflurane to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil.
干预措施: Desflurane (Drug)
Propofol
Patients will receive Propofol to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil.
干预措施: Propofol (Drug)
结局指标
主要结局
Incidence and severity of fatigue after anaesthesia based on propofol or desflurane
时间窗: Within the first week postoperatively
Fatigue scales; Chalder Fatigue Scale and Incidence-Consequence Fatigue Scale. Measure points; 1st, 3rd, 6th and 30th day postoperatively.
次要结局
- Incidence and severity of postoperative nausea after anaesthesia based on propofol or desflurane(Within the first week postoperatively)
- Fatigue scale validation(See under "Description":)
研究者
Torkjell Nostdahl
MD, Anaesthesiologist
Sykehuset Telemark