Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000805774
Ethics application status
Approved
Date submitted
17/07/2013
Date registered
22/07/2013
Date last updated
23/07/2019
Date data sharing statement initially provided
23/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of propofol sedation versus desflurane anaesthesia, used to supplement spinal anaesthesia, on the quality of recovery following hip replacement surgery in adult patients
Scientific title
A randomised trial of propofol sedation versus desflurane anaesthesia, used to supplement spinal anaesthesia, on the quality of recovery following hip replacement surgery in adult patients
Secondary ID [1] 282840 0
nil
Universal Trial Number (UTN)
U1111-1145-7188
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip surgery 289647 0
Anaesthesia 289648 0
Condition category
Condition code
Anaesthesiology 289965 289965 0 0
Anaesthetics
Surgery 289974 289974 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
For patients receiving propofol infusion, the dose will be adjusted according to sedation requirements by the anaesthetist (This may range fom 50-500 mg/hr via intravenous infusion). Patients will be spontaneously ventilating, with supplemental oxygen administered via a clear Hudson mask at 6 L /min. Supplemental midazolam (1-5 mg intravenous) is permitted. A BIS target of > 65 will be set for depth of sedation.

For patients receiving desflurane anesthesia they will receive intravenous induction of anesthesia with propofol (50-200 mg) followed by desflurane via inhalation. Ventilation will be via larangeal mask anesthesia and spontaneous ventilation unless the treating anaesthetist considers that endotracheal intubation and mechanical ventilation is required for the particular patient. The dose of desflurane will be adjusted according to the clinical requirement by the anaesthetist. A target BIS of 40-60 will be set for depth of anaesthesia.
Intervention code [1] 287531 0
Treatment: Drugs
Comparator / control treatment
sedation with propofol vs light general anaesthesia with desflurane
Control group
Active

Outcomes
Primary outcome [1] 290017 0
The primary endpoint will be the incidence of recovery in the cognitive domain of the PQRS at day 3.
Timepoint [1] 290017 0
Day 3 potoperative
Secondary outcome [1] 303780 0
Recovery for all domains, measured by the postoperative quality of recovery scale (PQRS) at 15 minutes, 40 minutes 1 and 3 days, 1 month and 3 months following cessation of anesthesia.
Timepoint [1] 303780 0
15 minutes, 40 minutes 1 and 3 days, 1 month and 3 months following cessation of anesthesia
Secondary outcome [2] 303781 0
Major adverse events including death, cardiovascular and respiratory complications, intensive care admission, neurological (such as stroke), and infection
Timepoint [2] 303781 0
Hospital admission

Eligibility
Key inclusion criteria
Adult patients undergoing hip replacement surgery under spinal anesthesia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients, who are not fluent in English will be excluded, as they may be unable to answer the recovery questionnaire adequately. Patients where either general or regional anesthesia is contraindicated, will be excluded

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)
Concealment will be by placing the card containing the allocation information in double opaque sealed envelopes, and concealment will be maintained until after recruitment and the patients is admitted into the operating theatre. The treating anaesthetist will then open the envelopes to reveal the allocation. A non-participant in any process of the study will perform preparation of the envelopes. A copy of the randomization sequence will be stored in a separate databank, which is password protected and not available to the investigators until the study is complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will by produced using a computer generated randomization sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary outcome, the proportion of patients recovered at day 3 in the cognitive domain will be analysed by Fishers exact test. For analysis of recovery between groups over time the Cochran Mantel Haenszel test on the proportions of recovery for each group with continuity correction over five measurement periods. Continuous data will be analyzed using independent samples t test, or RM ANOVA for repeated measurements.

Sample size estimates are based on the primary endpoint of cognitive recovery on day 3. In a previous study involving major joint replacement surgery, the incidence of cognitive recovery on day 3 was 61%. In order to detect a difference with an odds ratio of 2.5 (indicating a moderate size clinical effect) using Fisher’s exact test, with alpha size 0.05 and power 0.8, a sample size of 100 patients per group is required.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
30/08/2013
Actual
2/09/2013
Date of last participant enrolment
Anticipated
30/06/2016
Actual
4/04/2016
Date of last data collection
Anticipated
Actual
6/07/2016
Sample size
Target
200
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287621 0
Self funded/Unfunded
Name [1] 287621 0
Country [1] 287621 0
Primary sponsor type
University
Name
The University of Melbourne
Address
Grattan St
Carlton
Victoria, 3053
Country
Australia
Secondary sponsor category [1] 286364 0
None
Name [1] 286364 0
Address [1] 286364 0
Country [1] 286364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289590 0
Epworth Hospital HREC
Ethics committee address [1] 289590 0
Ethics committee country [1] 289590 0
Australia
Date submitted for ethics approval [1] 289590 0
Approval date [1] 289590 0
30/08/2013
Ethics approval number [1] 289590 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41478 0
Prof Colin Royse
Address 41478 0
The University of Melbourne
245 Cardigan St
Carlton
Vic 3095
Country 41478 0
Australia
Phone 41478 0
+61390354704
Fax 41478 0
Email 41478 0
[email protected]
Contact person for public queries
Name 41479 0
Colin Royse
Address 41479 0
The University of Melbourne
245 Cardigan St
Carlton
Vic 3095
Country 41479 0
Australia
Phone 41479 0
+61390354704
Fax 41479 0
Email 41479 0
[email protected]
Contact person for scientific queries
Name 41480 0
Colin Royse
Address 41480 0
The University of Melbourne
245 Cardigan St
Carlton
Vic 3095
Country 41480 0
Australia
Phone 41480 0
+61390354704
Fax 41480 0
Email 41480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy


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.