Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens
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|ClinicalTrials.gov Identifier: NCT01125982|
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : November 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Fatigue Nausea||Drug: Propofol Drug: Desflurane||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Postanaesthetic Outcome and Assessment of Fatigue in Day-surgery Laparoscopic Cholecystectomy|
|Study Start Date :||June 2010|
|Primary Completion Date :||July 2013|
|Study Completion Date :||July 2013|
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.
- Incidence and severity of fatigue after anaesthesia based on propofol or desflurane [ Time Frame: Within the first week postoperatively ]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 ]
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": ]
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125982
|Skien, Telemark, Norway, N-3710|