Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

Phase 4

Completed

• Conditions: Nausea; Fatigue
• Interventions: Drug: Desflurane; Drug: Propofol

• Registration Number: NCT01125982
• Lead Sponsor: Sykehuset Telemark

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Study Start: 2010-06
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desflurane	Desflurane	Patients will receive Desflurane to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil.
Propofol	Propofol	Patients will receive Propofol to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of fatigue after anaesthesia based on propofol or desflurane	Within the first week postoperatively	Fatigue scales; Chalder Fatigue Scale and Incidence-Consequence Fatigue Scale. Measure points; 1st, 3rd, 6th and 30th day postoperatively.

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of postoperative nausea after anaesthesia based on propofol or desflurane	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	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)

Trial Locations

Locations (1)

Telemark Hospital; 🇳🇴 Skien, Telemark, Norway