CompletedPhase 3ACTRN12609000445279

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.


Sponsor

Dr Roger Browning

Enrollment

120 participants

Start Date

Jun 15, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether the anti-nausea medication ondansetron can prevent shivering in women having a caesarean section under combined spinal-epidural anaesthesia. It is for women aged 18 and older who are scheduled for an elective caesarean delivery.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Ondansetron 8mg intravenously over 5 - 10 seconds

Ondansetron 8mg intravenously over 5 - 10 seconds


Locations(1)

Australia

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ACTRN12609000445279