Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

NCT ID: NCT01125982

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fatigue Nausea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Desflurane

Patients will receive Desflurane to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil.

Group Type ACTIVE_COMPARATOR

Desflurane

Intervention Type DRUG

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

Propofol

Patients will receive Propofol to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Interventions

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Propofol

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

Intervention Type DRUG

Desflurane

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

Intervention Type DRUG

Other Intervention Names

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Suprane

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sykehuset Telemark

OTHER_GOV

Sponsor Role lead

Responsible Party

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Torkjell Nostdahl

MD, Anaesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Telemark Hospital

Skien, Telemark, Norway

Site Status

Countries

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Norway

Other Identifiers

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2009-017117-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

09/15863

Identifier Type: OTHER

Identifier Source: secondary_id

2009/2171(REK)

Identifier Type: -

Identifier Source: org_study_id