Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01125982

Enrollment

130

Registered

2010-05-19

Start date

2010-06-30

Completion date

2013-07-31

Last updated

2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue, Nausea

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.

Interventions

DRUGPropofol

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

DRUGDesflurane

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence and severity of fatigue after anaesthesia based on propofol or desflurane	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

Measure	Time frame	Description
Incidence and severity of postoperative nausea after anaesthesia based on propofol or desflurane	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.
Fatigue scale validation	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)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026