Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125982
• Other study ID #: 2009/2171(REK)
• Secondary ID: 2009-017117-3009
• Status: Completed
• Phase: Phase 4
• First received: May 18, 2010
• Last updated: November 18, 2014
• Start date: June 2010
• Est. completion date: July 2013

Study information

• Verified date: November 2014
• Source: Sykehuset Telemark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Fatigue
• Nausea

Intervention

Drug:
• Propofol
Continuous intravenous infusion at 3-6 µg/mL (Ce - Target Controlled Infusion) during anaesthesia to provide sleep.
• Desflurane
Continuous inhalation at 0.7-0.8 MAC (endtidal) during anaesthesia to provide sleep

Locations

Country	Name	City	State
Norway	Telemark Hospital	Skien	Telemark

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset Telemark

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of fatigue after anaesthesia based on propofol or desflurane	Fatigue scales; Chalder Fatigue Scale and Incidence-Consequence Fatigue Scale. Measure points; 1st, 3rd, 6th and 30th day postoperatively.	Within the first week postoperatively	No
Secondary	Incidence and severity of postoperative nausea after anaesthesia based on propofol or desflurane	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	No
Secondary	Fatigue scale validation	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":	No