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Completed

NCT Number: NCT01125982

Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

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.

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Key information

Conditions

Fatigue Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Telemark Hospital

Skien, Telemark, N-3710, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

Continuous intravenous infusion at 3-6 µg/mL (Ce - Target Controlled Infusion) during anaesthesia to provide sleep.

Desflurane

Drug

Continuous inhalation at 0.7-0.8 MAC (endtidal) during anaesthesia to provide sleep

Other names: Suprane

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Sykehuset Telemark

Other Gov

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
May 19, 2010
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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