A randomised controlled trial of ondansetron to prevent shivering in women undergoing combined spinal epidural anaesthesia for elective caesarean section

Women undergoing combined spinal epidural for elective caesarean section, ondansetron 8mg versus placebo to prevent perioperative shivering.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000445279

Acronym

OSCAR Trial

Enrollment

120

Registered

2009-06-12

Start date

2009-06-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

Ondansetron 8mg intravenously over 5 - 10 seconds

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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

Outcome results