Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

Study Overview
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Brief Summary
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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.

Official Title
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Postanaesthetic Outcome and Assessment of Fatigue in Day-surgery Laparoscopic Cholecystectomy

Conditions
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Fatigue, Nausea

Intervention / Treatment
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* Drug: Propofol
* Drug: Desflurane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Desflurane<br>Patients will receive Desflurane to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil. | Drug: Desflurane<br>* Continuous inhalation at 0.7-0.8 MAC (endtidal) during anaesthesia to provide sleep<br>* Other names: Suprane;|
| Active Comparator: Propofol<br>Patients will receive Propofol to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil. | Drug: Propofol<br>* Continuous intravenous infusion at 3-6 µg/mL (Ce - Target Controlled Infusion) during anaesthesia to provide sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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: |