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Trial registered on ANZCTR


Registration number
ACTRN12609000445279
Ethics application status
Approved
Date submitted
10/03/2009
Date registered
12/06/2009
Date last updated
29/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of ondansetron to prevent shivering in women undergoing combined spinal epidural anaesthesia for elective caesarean section
Scientific title
Women undergoing combined spinal epidural for elective caesarean section, ondansetron 8mg versus placebo to prevent perioperative shivering.
Secondary ID [1] 280576 0
Nil
Universal Trial Number (UTN)
Trial acronym
OSCAR Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shivering during combined spinal epidural anaesthesia 4444 0
Condition category
Condition code
Anaesthesiology 4713 4713 0 0
Anaesthetics
Reproductive Health and Childbirth 237301 237301 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ondansetron 8mg intravenously over 5 - 10 seconds
Intervention code [1] 4190 0
Prevention
Comparator / control treatment
4 ml saline intravenously over 5 - 10 seconds
Control group
Placebo

Outcomes
Primary outcome [1] 5582 0
Incidence of shivering using the validated Wrench scoring scale of 0 - 4, as assessed visually by the treating anaesthetist.
Timepoint [1] 5582 0
Continuously assessed during the following three time periods: Post combined-spinal epidural, During surgery, In Recovery room. Monitoring will cease when the patient is discharged to the ward.
Secondary outcome [1] 9408 0
Itch: Assessed by verbal questioning of the patient as either present or not present.
Timepoint [1] 9408 0
Continuously assessed in the following three time periods: After combined spinal epidural, During surgery, In recovery room. Monitoring will cease when the patient is discharged to the ward
Secondary outcome [2] 9409 0
Nausea: Assessed by verbal questioning of the patient as either present or not present.
Timepoint [2] 9409 0
Continuously assessed in the following three time periods: After combined spinal epidural, During surgery, In recovery room. Monitoring will cease when the patient is discharged to the ward

Eligibility
Key inclusion criteria
American Society of Anesthesiologists (ASA) Score 1 or 2
18 years of age or older
Elective caeasarean section under combined spinal epidural anaesthesia
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Preoperative use of ondansetron, clonidine, pethidine or tramadol
Contraindication to combined spinal epidural anaesthesia
Preoperative shivering
Intolerance or allergy to ondansetron
Failure to find subarachnoid space during combined spinal epidural anaesthesia
Conversion to general anaesthesia
Adminstration of intrathecal or epidural morphine

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4637 0
Hospital
Name [1] 4637 0
Fremantle Hospital
Address [1] 4637 0
Alma Street
Fremantle
Western Australia
6160
Country [1] 4637 0
Australia
Funding source category [2] 237128 0
Self funded/Unfunded
Name [2] 237128 0
Address [2] 237128 0
Country [2] 237128 0
Australia
Primary sponsor type
Individual
Name
Dr Roger Browning
Address
Department Anaesthesia and Pain Medicine
Fremantle Hospital
P.O. Box 480
Fremantle WA 6959
Country
Australia
Secondary sponsor category [1] 4181 0
None
Name [1] 4181 0
Address [1] 4181 0
Country [1] 4181 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6675 0
South Metropolitan Area Health Service Human Research Ethics Committee
Ethics committee address [1] 6675 0
Ethics committee country [1] 6675 0
Australia
Date submitted for ethics approval [1] 6675 0
24/03/2009
Approval date [1] 6675 0
Ethics approval number [1] 6675 0

Summary
Brief summary
In Australia Caesarean section is most commonly performed under regional anaesthesia, usually spinal or epidural. These techniques are associated with a significant incidence of shivering which can cause the mother significant distress, prevent her from holding her baby & interfere with monitoring of blood pressure and other vital signs. Ondansetron is a widely used anti – nausea drug, with a good safety profile and very few adverse effects. It has been shown to reduce the incidence & severity of shivering in non obstetric patients undergoing regional or general anaesthesia. We plan to investigate whether the prophylactic administration of ondansetron prior to regional anaesthesia will decrease the incidence and severity of shivering in women undergoing elective caesarean section.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29372 0
Address 29372 0
Country 29372 0
Phone 29372 0
Fax 29372 0
Email 29372 0
Contact person for public queries
Name 12619 0
Dr Roger Browning
Address 12619 0
Department of Anaesthesia and Pain Medicine
Fremantle Hospital
P.O. Box 480
Fremantle WA 6959
Country 12619 0
Australia
Phone 12619 0
+ 61 8 94312551
Fax 12619 0
Email 12619 0
roger.browning@health.wa.gov.au
Contact person for scientific queries
Name 3547 0
Dr Roger Browning
Address 3547 0
Dept Anaesthesia and Pain Medicine
Fremantle Hospital
P.O. Box 480
Fremantle WA 6959
Country 3547 0
Australia
Phone 3547 0
+ 61 8 94312551
Fax 3547 0
Email 3547 0
roger.browning@health.wa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary