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

Inclusion Criteria3

  • American Society of Anesthesiologists (ASA) Score 1 or 2
  • years of age or older
  • Elective caeasarean section under combined spinal epidural anaesthesia

Exclusion Criteria7

  • 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

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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