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

Phase 3

Completed

• Conditions: Shivering during combined spinal epidural anaesthesia; Anaesthesiology - Anaesthetics; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12609000445279
• Lead Sponsor: Dr Roger Browning

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of shivering using the validated Wrench scoring scale of 0 - 4, as assessed visually by the treating anaesthetist.[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 Measures

Name	Time	Method
Itch: Assessed by verbal questioning of the patient as either present or not present.[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];Nausea: Assessed by verbal questioning of the patient as either present or not present.[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]