Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

Sykehuset Telemark

Status and phase: Completed; Phase 4

Conditions: Nausea; Fatigue

Treatments: Drug: Propofol; Drug: Desflurane

Study type: Interventional

Funder types: Other

Identifiers

NCT01125982

2009/2171(REK)

2009-017117-30 (EudraCT Number)

09/15863 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 2 patient groups

Desflurane

Active Comparator group

Description:

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

Treatment:

Drug: Desflurane

Propofol

Active Comparator group

Description:

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

Treatment:

Drug: Propofol