Does Higher OT Temperature and IV Ondansetron Reduce Incidence of PSS in Parturients?

Summary

This study will look at the incidence of post-spinal shivering (PSS) among the obstetrics population and will investigate whether higher operation theater (OT) temperature range or/and IV Ondansetron are able to reduce the incidence of PSS. This is a double-blind, randomized, factorial study, patients will be grouped into 4 groups - LP, HP, LO, HO (L= low-temperature range, H= high-temperature range, P= placebo, O=Ondansetron). All patients undergoing cesarean section under spinal anesthesia will be recruited, and it will be conducted in obstetrics OT.

Conditions

• Temperature Change, Body
• Chills
• Tremor
• Nausea, Postoperative
• Vomiting, Postoperative
• Postoperative Shivering

Interventions

DRUG

IV Ondansetron 4mg

IV ondansetron 4mg

OTHER

Higher OT temperature range

OT temperature set to 19-22 degree celsius

DRUG

Placebo

IV Normal Saline 2cc will be given

OTHER

Lower OT temperature Range

OT temperature set to 17-19 degree celsius

Sponsors & Collaborators

• Dr Lim Siu Min

  lead OTHER

Principal Investigators

• SIU MIN LIM, L · MALAYA UNIVERSITY

• SOOK HUI CHAW, AP · MALAYA UNIVERSITY

• CAROLYN YIM CHUE WAI, AP · MALAYA UNIVERSITY

• JAUHARATUNNUR ISHAK, M · MALAYA UNIVERSITY

• TSYR XIANG TEOH, M · MALAYA UNIVERSITY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-13

Primary Completion

2022-12-30

Completion

2022-12-30

Countries

• Malaysia

Study Locations