Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens
|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|
|Study Completion Date:||July 2013|
|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
|Skien, Telemark, Norway, N-3710|