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

  • STATUS
    Recruiting
  • days left to enroll
    90
  • participants needed
    628
  • sponsor
    Dr Lim Siu Min
Updated on 21 October 2021
Accepts healthy volunteers

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.

Description

Many studies have been conducted to look at methods to prevent and treat postspinal shivering. However, there is still no clear protocol or gold standard for post-spinal shivering management. This is due to the fact that post-spinal shivering mechanisms are complex and are broadly grouped into thermoregulatory and non-thermoregulatory. Preventive measures that have been studied are broadly classified into pharmacological methods and non-pharmacological methods. For Non-pharmacological method, active warming of the patient by various methods have been found to be effective in preventing PSS. However, there is no study that looks at ways to reduce heat loss hence maintaining normothermia and preventing PSS in patients. Therefore in this study, we will be investigating if higher OT temperature will reduce the incidence of PSS. As for pharmacological methods, many drugs have been studied for examples analgesics (tramadol), opioid receptor agonists (pethidine, fentanyl), cholinesterase inhibitors (physostigmine), N-methyl-D-aspartate receptor antagonists (ketamine, magnesium sulphate), 2-central agonists (clonidine, dexmedetomidine), antiserotonergic (ondansetron) and anti-inflammatory drugs (dexamethasone). Ondansetron is usually used to prevent chemotherapy or radiotherapy-induced nausea vomiting and Post-operative nausea and vomiting. Due to the fact that it is generally a safe drug and has added benefit as an anti-emetics especially for obstetrics population, this drug is chosen to be studied. We will also look at the efficacy of the combined effect of increased OT temperature and prophylaxis ondansetron on preventing PSS.

Details
Condition postoperative vomiting, Post-Operative Nausea and Vomiting, shakes, Postoperative Nausea, shake, Tremor, Postoperative Shivering, Body Temperature Changes, Chills
Treatment Placebo, IV Ondansetron 4mg, Higher OT temperature range, Lower OT temperature Range
Clinical Study IdentifierNCT04654429
SponsorDr Lim Siu Min
Last Modified on21 October 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note