Fatigue Clinical Trial
Official title:
Postanaesthetic Outcome and Assessment of Fatigue in Day-surgery Laparoscopic Cholecystectomy
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.
Status | Completed |
Enrollment | 130 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Norway | Telemark Hospital | Skien | Telemark |
Lead Sponsor | Collaborator |
---|---|
Sykehuset Telemark |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and severity of fatigue after anaesthesia based on propofol or desflurane | Fatigue scales; Chalder Fatigue Scale and Incidence-Consequence Fatigue Scale. Measure points; 1st, 3rd, 6th and 30th day postoperatively. | Within the first week postoperatively | No |
Secondary | Incidence and severity of postoperative nausea after anaesthesia based on propofol or desflurane | PONV scales; 4-point Likert Scale and 11-point NRS Scale. Measure points; 1st, 3rd, 6th and 30th day postoperatively. |
Within the first week postoperatively | No |
Secondary | Fatigue scale validation | 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) |
See under "Description": | No |
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