Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

NCT01125982 | Completed Phase 4

• 3 other identifiers: 2009/2171(REK)2009-017117-3009/15863
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Nausea

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Incidence and severity of postoperative nausea after anaesthesia based on propofol or desflurane

  Within the first week postoperatively

• Fatigue scale validation

  See under "Description":

Study Arms (2)

Desflurane

ACTIVE COMPARATOR

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

Drug: Desflurane

Propofol

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

Propofol DRUG

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

Propofol

Desflurane DRUG

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

Also known as: Suprane

Desflurane

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sykehuset Telemark: lead

Study Sites (1)

Telemark Hospital

Skien, Telemark, N-3710, Norway

Location

MeSH Terms

Conditions

Fatigue; Nausea

Interventions

Propofol; Desflurane

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anaesthesiologist

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: May 19, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

NO (1)