Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Sykehuset Telemark
Sponsor:
Information provided by (Responsible Party):
Torkjell Nostdahl, Sykehuset Telemark
ClinicalTrials.gov Identifier:
NCT01125982
First received: May 18, 2010
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Fatigue
Nausea
Drug: Propofol
Drug: Desflurane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Postanaesthetic Outcome and Assessment of Fatigue in Day-surgery Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Sykehuset Telemark:

Primary Outcome Measures:
  • Incidence and severity of fatigue after anaesthesia based on propofol or desflurane [ Time Frame: Within the first week postoperatively ] [ Designated as safety issue: No ]
    Fatigue scales; Chalder Fatigue Scale and Incidence-Consequence Fatigue Scale. Measure points; 1st, 3rd, 6th and 30th day postoperatively.


Secondary Outcome Measures:
  • Incidence and severity of postoperative nausea after anaesthesia based on propofol or desflurane [ Time Frame: Within the first week postoperatively ] [ Designated as safety issue: No ]

    PONV scales; 4-point Likert Scale and 11-point NRS Scale.

    Measure points; 1st, 3rd, 6th and 30th day postoperatively.


  • Fatigue scale validation [ Time Frame: See under "Description": ] [ Designated as safety issue: No ]

    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)



Estimated Enrollment: 126
Study Start Date: June 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125982

Contacts
Contact: Torkjell Nostdahl, MD +47-35003500 tn.epost@gmail.com

Locations
Norway
Telemark Hospital Recruiting
Skien, Telemark, Norway, N-3710
Principal Investigator: Torkjell Nostdahl, MD         
Sponsors and Collaborators
Sykehuset Telemark
  More Information

Additional Information:
No publications provided

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, 09/15863
Study First Received: May 18, 2010
Last Updated: June 7, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

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

ClinicalTrials.gov processed this record on July 22, 2014