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Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

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ClinicalTrials.gov Identifier: NCT01125982
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
Torkjell Nostdahl, 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.

Condition or disease Intervention/treatment Phase
Fatigue Nausea Drug: Propofol Drug: Desflurane Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Postanaesthetic Outcome and Assessment of Fatigue in Day-surgery Laparoscopic Cholecystectomy
Study Start Date : June 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: 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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.


  2. 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)




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125982


Locations
Norway
Telemark Hospital
Skien, Telemark, Norway, N-3710
Sponsors and Collaborators
Sykehuset Telemark

Responsible Party: Torkjell Nostdahl, MD, Anaesthesiologist, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT01125982     History of Changes
Other Study ID Numbers: 2009/2171(REK)
2009-017117-30 ( EudraCT Number )
09/15863 ( Other Identifier: Norwegian Medicines Agency )
First Posted: May 19, 2010    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Fatigue
Nausea
Signs and Symptoms
Signs and Symptoms, Digestive
Anesthetics
Propofol
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation