Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

November 18, 2014 updated by: Torkjell Nostdahl, Sykehuset Telemark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Telemark
      • Skien, Telemark, Norway, N-3710
        • Telemark Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Within the first week 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)
See under "Description":

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Telemark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (Estimate)

May 19, 2010

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/2171(REK)
  • 2009-017117-30 (EudraCT Number)
  • 09/15863 (Other Identifier: Norwegian Medicines Agency)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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