Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000362099
Ethics application status
Approved
Date submitted
30/04/2010
Date registered
6/05/2010
Date last updated
12/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Postoperative sleep disturbances and quality of sleep after Remifentanil or Fentanyl –based anaesthesia
Scientific title
Postoperative sleep disturbances and quality of sleep after Remifentanil or Fentanyl –based anaesthesia in patients undergoing elective surgery
Secondary ID [1] 251684 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long-term postoperative sleep disturbances 257271 0
Condition category
Condition code
Anaesthesiology 257419 257419 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients receive remifentanil-based anaesthesia during their elective operation. This is a one off treatment. Remifentanil is continuously infused intravenously at a rate of 0.15 - 0.3 mcg/kg/min. The infusion starts on induction of anaesthesia and finishes after the surgical procedure before emergence. Approximate duration of anaesthesia is between 45 and 120 minutes.
Intervention code [1] 256390 0
Treatment: Drugs
Comparator / control treatment
Patients receive fentanyl-based anaesthesia during their elective operation. For induction of anaesthesia, patients receive 0.5 - 1.5 mcg / kg fentanyl for induction of anaesthesia. During the procedure, repetitive doses of 0.5 - 1 mcg / kg, as clinically appropiate. Duration of anaesthesia is between 45 and 120 minutes.
Control group
Active

Outcomes
Primary outcome [1] 258337 0
Changes in postoperative quality of sleep 3 months postoperatively are assessed using the Pittsburgh Sleep Quality Quality Index (PSQI).
Timepoint [1] 258337 0
3 months postoperatively
Secondary outcome [1] 264055 0
Changes in postoperative quality of sleep 6 months postoperatively are assessed using the Pittsburgh Sleep Quality Quality Index (PSQI).
Timepoint [1] 264055 0
6 months postoperatively

Eligibility
Key inclusion criteria
Surgery under general anaesthesia
Perioperative Anaesthesia Risk Status according to American Association of Anesthesiology (ASA) I-III
Estimated anaesthesia time > 60 minutes
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age< 18, Head Injury, Cardiac Surgery, Alcohol addiction, Other drug addictions, ASA > III, incapacity to consent, medication with drugs known to potentially interact with sleep quality (e.g. benzodiazepines, ketamine, beta-receptor-blockers), previous and continueing use of opioids.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Identified from theatre list. Written informed consent as per ethical guidelines. Allocation concealment by sealed opaque envelopes. Patients blinded to intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randon number generator using computerized sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256895 0
Self funded/Unfunded
Name [1] 256895 0
Manuel Wenk
Country [1] 256895 0
Australia
Primary sponsor type
Individual
Name
Manuel Wenk
Address
Royal Perth Hospital
Wellington Street Campus
Perth 6000
WA
Country
Australia
Secondary sponsor category [1] 256166 0
None
Name [1] 256166 0
Address [1] 256166 0
Country [1] 256166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258905 0
Royal Perth Ethics Committee
Ethics committee address [1] 258905 0
Royal Perth Hospital
Wellington Street Campus
Perth 6000
WA
Ethics committee country [1] 258905 0
Australia
Date submitted for ethics approval [1] 258905 0
Approval date [1] 258905 0
23/04/2010
Ethics approval number [1] 258905 0
EC 2010/019

Summary
Brief summary
Modern anaesthesia incorporates the use of short-acting opioids such as remifentanil. Lately, there has been emerging evidence in the literature that some opioids might influence postoperative sleep quality for up to many months. We aim to compare sleep quality after exposure to 2 opioids regularly used in the clinical routine at Royal Perth Hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31112 0
Address 31112 0
Country 31112 0
Phone 31112 0
Fax 31112 0
Email 31112 0
Contact person for public queries
Name 14359 0
Dr Manuel Wenk
Address 14359 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street Campus
Perth 6000
WA
Country 14359 0
Australia
Phone 14359 0
+ 61 8 93841036
Fax 14359 0
Email 14359 0
[email protected]
Contact person for scientific queries
Name 5287 0
Dr Manuel Wenk
Address 5287 0
Department of Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street Campus
Perth 6000
WA
Country 5287 0
Australia
Phone 5287 0
+ 61 8 93841036
Fax 5287 0
Email 5287 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.