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Clinical Trials/NCT01125982
NCT01125982
Completed
Phase 4

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

Sykehuset Telemark1 site in 1 country130 target enrollmentJune 2010

Overview

Phase
Phase 4
Intervention
Desflurane
Conditions
Fatigue
Sponsor
Sykehuset Telemark
Enrollment
130
Locations
1
Primary Endpoint
Incidence and severity of fatigue after anaesthesia based on propofol or desflurane
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
July 2013
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sykehuset Telemark
Responsible Party
Principal Investigator
Principal Investigator

Torkjell Nostdahl

MD, Anaesthesiologist

Sykehuset Telemark

Eligibility Criteria

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

Arms & Interventions

Desflurane

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

Intervention: Desflurane

Propofol

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

Intervention: Propofol

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Incidence and severity of postoperative nausea after anaesthesia based on propofol or desflurane(Within the first week postoperatively)
  • Fatigue scale validation(See under "Description":)

Study Sites (1)

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