FatiguePhase 4NCT01125982
Postoperative Fatigue and Nausea Related to Choice of Anaesthetic Regimens
A Phase 4 study testing Propofol and Desflurane in people with Fatigue and Nausea, run by Sykehuset Telemark at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Propofol and Desflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2010to Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Known or suspected Malignant Hyperthermia or Porphyria
- Fatigue-related diagnosis
- Recently received adjuvant therapy (chemotherapy, radiotherapy)
- Severe chronic pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postanaesthetic Outcome and Assessment of Fatigue in Day-surgery Laparoscopic Cholecystectomy
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.
- Being tested
- Propofol, Desflurane
- Medical subject headings
- Fatigue, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Continuous intravenous infusion at 3-6 µg/mL (Ce - Target Controlled Infusion) during anaesthesia to provide sleep.
DesfluraneDrug
Also called Suprane
Continuous inhalation at 0.7-0.8 MAC (endtidal) during anaesthesia to provide sleep
| Study group | Role | What they receive |
|---|---|---|
| Desflurane | Active comparator | Patients will receive Desflurane to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil. Receives: Drug: Desflurane |
| Propofol | Active comparator | Patients will receive Propofol to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the first week postoperatively
Secondary outcomes (2)
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.
Measured: Within the first week 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)
Measured: See under "Description":
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Torkjell Nostdahl, Sykehuset Telemark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125982
- Sponsor's protocol ID
- 2009/2171(REK)
- Other IDs
- 2009-017117-30, 09/15863, 2009
- Status last verified
- Nov 2014
- First submitted
- 18 May 2010
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postanaesthetic Outcome and Assessment of Fatigue in Day-surgery Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01125982
- Acronym / sponsor ID
- 2009/2171(REK)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Sykehuset TelemarkOther government
- Study start
- Jun 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 19 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desflurane | Active comparator | Drug: DesfluranePatients will receive Desflurane to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil. |
| Propofol | Active comparator | Drug: PropofolPatients will receive Propofol to provide sleep during anaesthesia for laparoscopic cholecystectomy. Analgesia will be provided by remifentanil. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Serious illness (ASA 3-4)
- Pregnancy or suspected pregnancy
- Breastfeeding women
- Contraindications to use of NSAIDs
- Serious allergic reaction to anaesthetics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolContinuous intravenous infusion at 3-6 µg/mL (Ce - Target Controlled Infusion) during anaesthesia to provide sleep. | Drug | Propofol |
| DesfluraneAlso: SupraneContinuous inhalation at 0.7-0.8 MAC (endtidal) during anaesthesia to provide sleep | Drug | Desflurane |
Primary outcome
Incidence and severity of fatigue after anaesthesia based on propofol or desflurane
Time frame: Within the first week postoperatively
Fatigue scales; Chalder Fatigue Scale and Incidence-Consequence Fatigue Scale. Measure points; 1st, 3rd, 6th and 30th day postoperatively.
2 secondary outcomes
Incidence and severity of postoperative nausea after anaesthesia based on propofol or desflurane
Time frame: Within the first week postoperatively
Fatigue scale validation
Time frame: See under "Description":
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Desflurane in people with Fatigue and Nausea, run by Sykehuset Telemark at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of fatigue after anaesthesia based on propofol or desflurane (time frame: Within the first week postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2014.