Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|Official Title:||Postanaesthetic Outcome and Assessment of Fatigue in Day-surgery Laparoscopic Cholecystectomy|
- Incidence and severity of fatigue after anaesthesia based on propofol or desflurane [ Time Frame: Within the first week postoperatively ] [ Designated as safety issue: No ]Fatigue scales; Chalder Fatigue Scale and Incidence-Consequence Fatigue Scale. Measure points; 1st, 3rd, 6th and 30th day postoperatively.
- Incidence and severity of postoperative nausea after anaesthesia based on propofol or desflurane [ Time Frame: Within the first week postoperatively ] [ Designated as safety issue: No ]
PONV scales; 4-point Likert Scale and 11-point NRS Scale.
Measure points; 1st, 3rd, 6th and 30th day postoperatively.
- Fatigue scale validation [ Time Frame: See under "Description": ] [ Designated as safety issue: No ]
To ensure validated outcome measures we will perform validation and comparison of two different fatigue scales (Chalder Fatigue Scale and Identity-Consequences Fatigue Scale). This will primarily be performed in a mixed surgical population. In addition the scales will also be validated in palliative patients, patients with possible CFS/ME diagnosis and patients with chronic pain.
Data aquisition will be cross-sectional, but the surgical population will also yield longitudinal data (preop. and 3rd postoperative day)
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Desflurane
Patients will receive Desflurane to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil.
Continuous inhalation at 0.7-0.8 MAC (endtidal) during anaesthesia to provide sleep
Other Name: Suprane
Active Comparator: Propofol
Patients will receive Propofol to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil.
Continuous intravenous infusion at 3-6 µg/mL (Ce - Target Controlled Infusion) during anaesthesia to provide sleep.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01125982
|Contact: Torkjell Nostdahl, MDemail@example.com|
|Skien, Telemark, Norway, N-3710|
|Principal Investigator: Torkjell Nostdahl, MD|