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

Tremor Clinical Trial

— HOTON  

Official title:

Does Higher Operation Theatre Ambient Temperature and Intravenous Ondansetron Prophylaxis Reduce Incidence of Post-spinal Shivering in Obstetric Population? A Double-blind, Randomised, Factorial Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04654429
• Other study ID #: NMRR-20-2158-56283
• Secondary ID: 202073-8861
• Status: Recruiting
• Phase: Phase 4
• Start date: October 13, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: October 2021
• Source: University of Malaya
• Contact: SIU MIN LIM, L
• Phone: 6017-7337750
• Email: limsiumin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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), α2-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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 628
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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:

1. Patients who refused to provide study consent

2. Caesarean section planned under general or epidural anaesthesia or potential conversion to general anaesthesia intraoperatively

3. Royal College of Obstetrics and Gynaecology (RCOG) classification of urgency caesarean section Grade I - Immediate threat to life of woman and child. (29)

4. Patients with psychiatric disorders who are taking selective serotonin reuptake inhibitor (SSRI) and serotonin-noradrenaline reuptake inhibitor (SNRI)

5. 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

6. Patients with history of allergic / hypersensitive reactions towards ondansetron.

7. Patients who received ondansetron intraoperatively as anti-emetics.

8. Recruited patients will be excluded if OT temperature on the day of recruitment does not fulfil the OT temperature range fixed for the study

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Center	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
Dr Lim Siu Min

Country where clinical trial is conducted

Malaysia, 

References & Publications (5)

Alfonsi P. Postanaesthetic shivering. Epidemiology, pathophysiology and approaches to prevention and management. Minerva Anestesiol. 2003 May;69(5):438-42. Review. — View Citation

Choi KE, Park B, Moheet AM, Rosen A, Lahiri S, Rosengart A. Systematic Quality Assessment of Published Antishivering Protocols. Anesth Analg. 2017 May;124(5):1539-1546. doi: 10.1213/ANE.0000000000001571. Review. — View Citation

Crowley LJ, Buggy DJ. Shivering and neuraxial anesthesia. Reg Anesth Pain Med. 2008 May-Jun;33(3):241-52. doi: 10.1016/j.rapm.2007.11.006. Review. — View Citation

Horn EP, Schroeder F, Gottschalk A, Sessler DI, Hiltmeyer N, Standl T, Schulte am Esch J. Active warming during cesarean delivery. Anesth Analg. 2002 Feb;94(2):409-14, table of contents. — View Citation

Varshney RK, Garg M, Kapoor K, Jheetay GS. The role of ramosetron in the prevention of post-spinal shivering in obstetric patients. A prospective randomized double blind study. Rom J Anaesth Intensive Care. 2019 Apr;26(1):37-43. doi: 10.2478/rjaic-2019-00 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Demonstrate higher OT temperature range ( 19.1- 22.0 degree Celcius) is effective in reducing the incidence PSS in parturients.	Assessment of patient's shivering grade according to Crossley and Mahajan classification in both Higher temperature range group ( 19.1 -22.0 degree Celcius) compared to lower OT temperature range group (17.0 - 19.0 degree Celcius) Grade 0 - No Shivering Grade 1 - No visible muscle activity, but one or more of piloerection , peripheral vasoconstriction or peripheral cyanosis ( other causes excluded) Grade 2 - Muscular activity in only one muscle group Grade 3 - Moderate muscle activity in more than one muscle group but not generalised shaking Grade 4 - Violent muscular that involves the entire body	1 year
Primary	To demonstrate IV Ondansetron is effective in reducing the incidence of PSS in parturient undergoing LSCS.	Assessment of patient's shivering grade according to Crossley and Mahajan classification in both patients receiving placebo group vs receiving Ondansetron group: Grade 0 - No Shivering Grade 1 - No visible muscle activity, but one or more of piloerection , peripheral vasoconstriction or peripheral cyanosis ( other causes excluded) Grade 2 - Muscular activity in only one muscle group Grade 3 - Moderate muscle activity in more than one muscle group but not generalised shaking Grade 4 - Violent muscular that involves the entire body	1 year
Secondary	To determine the incidence of PSS	Number patients of with shivering grade 3 and above.	1 year
Secondary	To determine the average threshold body temperature, °C at which shivering occur.	To determine the average range of temperature that grade 3 and above shivering occurred among the recruited population from linear graph	1 year
Secondary	To determine the change in body temperature (mean d Temp °C) at which shivering occur	To assess average temperature drop in order for shivering to occur from linear graph	1 year
Secondary	To determine if higher OT temperature range with IV Ondansetron (HO group) is superior to individual intervention alone in reducing the incidence of PSS	Assessment of patient's shivering grade according to Crossley and Mahajan classification	1 year