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Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

Primary Purpose

Fatigue, Nausea

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Propofol
Desflurane
Sponsored by
Sykehuset Telemark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fatigue

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Telemark Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Desflurane

Propofol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)

Full Information

First Posted
May 18, 2010
Last Updated
November 18, 2014
Sponsor
Sykehuset Telemark
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1. Study Identification

Unique Protocol Identification Number
NCT01125982
Brief Title
Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens
Official Title
Postanaesthetic Outcome and Assessment of Fatigue in Day-surgery Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sykehuset Telemark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Nausea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desflurane
Arm Type
Active Comparator
Arm Description
Patients will receive Desflurane to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil.
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Patients will receive Propofol to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Continuous intravenous infusion at 3-6 µg/mL (Ce - Target Controlled Infusion) during anaesthesia to provide sleep.
Intervention Type
Drug
Intervention Name(s)
Desflurane
Other Intervention Name(s)
Suprane
Intervention Description
Continuous inhalation at 0.7-0.8 MAC (endtidal) during anaesthesia to provide sleep
Primary Outcome Measure Information:
Title
Incidence and severity of fatigue after anaesthesia based on propofol or desflurane
Description
Fatigue scales; Chalder Fatigue Scale and Incidence-Consequence Fatigue Scale. Measure points; 1st, 3rd, 6th and 30th day postoperatively.
Time Frame
Within the first week postoperatively
Secondary Outcome Measure Information:
Title
Incidence and severity of postoperative nausea after anaesthesia based on propofol or desflurane
Description
PONV scales; 4-point Likert Scale and 11-point NRS Scale. Measure points; 1st, 3rd, 6th and 30th day postoperatively.
Time Frame
Within the first week postoperatively
Title
Fatigue scale validation
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)
Time Frame
See under "Description":

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Telemark Hospital
City
Skien
State/Province
Telemark
ZIP/Postal Code
N-3710
Country
Norway

12. IPD Sharing Statement

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Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens

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