Does Higher OT Temperature and IV Ondansetron Reduce Incidence of PSS in Parturients? (NCT04654429) | Clinical Trial Compass
UnknownPhase 4
Does Higher OT Temperature and IV Ondansetron Reduce Incidence of PSS in Parturients?
Malaysia628 participantsStarted 2020-10-13
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To Demonstrate higher OT temperature range ( 19.1- 22.0 degree Celcius) is effective in reducing the incidence PSS in parturients.
Timeframe: 1 year
2
To demonstrate IV Ondansetron is effective in reducing the incidence of PSS in parturient undergoing LSCS.