Does Higher OT Temperature and IV Ondansetron Reduce Incidence of PSS in Parturients? (HOTON)
Temperature Change, Body, Chills, Tremor
About this trial
This is an interventional prevention trial for Temperature Change, Body focused on measuring Post-spinal shivering, Subarachnoid block, obstetrics, caesarean section, temperature, ondansetron, factorial study
Eligibility Criteria
Inclusion Criteria:
- All elective and emergency obstetric patients who are going for lower segment caesarean section (LSCS) under spinal anaesthesia in UMMC.
- Patient who are given combined spinal epidural anaesthesia (CSE) without epidural local anaesthetic top-up will be included.
Exclusion Criteria:
- Patients who refused to provide study consent
- Caesarean section planned under general or epidural anaesthesia or potential conversion to general anaesthesia intraoperatively
- Royal College of Obstetrics and Gynaecology (RCOG) classification of urgency caesarean section Grade I - Immediate threat to life of woman and child. (29)
- Patients with psychiatric disorders who are taking selective serotonin reuptake inhibitor (SSRI) and serotonin-noradrenaline reuptake inhibitor (SNRI)
- Patients who has problems with any types of tremor or involuntary movements and neuromuscular disorders such as Parkinson Disease and muscular dystrophy will be excluded from the study as this will interfere with the clinical interpretation of shivering
- Patients with history of allergic / hypersensitive reactions towards ondansetron.
- Patients who received ondansetron intraoperatively as anti-emetics.
- Recruited patients will be excluded if OT temperature on the day of recruitment does not fulfil the OT temperature range fixed for the study
Sites / Locations
- University Malaya Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Lower OT temperature with placebo (LP)
Higher OT temperature with placebo (HP)
Lower OT temperature with IV Ondansetron 4mg (LO)
higher OT temperature 19-22 and IV ondansetron 4mg (HO)
Lower OT temperature with placebo This group function as a main control arm. Incidence of PSS will be documented usual / standard OT temperature which is 17-19 degree celsius, and without giving any pharmacological intervention to prevent PSS.
Higher OT temperature with placebo This group will receive one non-pharmacological intervention, which is higher OT temperature 19-22 degree celsius. The aim of this intervention is to reduce heat loss therefore incidence of PSS for obstetric population coming for lower segment cesarean section (LSCS) by reducing the temperature gradient between the body and environment.
Lower OT temperature with Ondansetron 4mg intravenous. This group also will receive one pharmacological intervention, which is IV ondansetron 4mg to prevent incidence of PSS under standard OT temperature 17-19 degrees.
This group will receive 2 interventions - higher OT temperature 19-22 and IV ondansetron 4mg. This group is designed to see if when both intervention combined, will further reduce the incidence of PSS among obstetrics population.