Clinical trial NCT04654429: Does Higher OT Temperature and IV Ondansetron Reduce Incidence of PSS in Parturients?
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Temperature Change, Body
Chills
Tremor
Nausea, Postoperative
Vomiting, Postoperative
Postoperative Shivering
Keywords: Post-spinal shivering
Subarachnoid block
obstetrics
caesarean section
temperature
ondansetron
factorial study
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 628
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: All patients participating in this study will be randomised two times into 4 groups: LP, HP, LO, HO (L= low-temperature range, H= high-temperature range, P= placebo, O=Ondansetron). The OT temperature will be set to a random range on every Monday, 7am to either lower temperature range group (17.0-19.0⁰C), set at 18.0⁰C; or higher temperature range group (19.1-22.0⁰C), set at 21.0⁰C by an OT engineer who is not involved in this study. OT engineer will open a sealed opaque envelope which contains target temperature to be set for the week, which is randomised prior using computer generated sequence. The temperature setting will maintain for one week and change on the following Monday 7am.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

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:

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

Primary outcomes:
measure: To Demonstrate higher OT temperature range ( 19.1- 22.0 degree Celcius) is effective in reducing the incidence PSS in parturients.
timeFrame: 1 year
measure: To demonstrate IV Ondansetron is effective in reducing the incidence of PSS in parturient undergoing LSCS.
timeFrame: 1 year
Secondary outcomes:
measure: To determine the incidence of PSS
timeFrame: 1 year
measure: To determine the average threshold body temperature, ⁰C at which shivering occur.
timeFrame: 1 year
measure: To determine the change in body temperature (mean δ Temp ⁰C) at which shivering occur
timeFrame: 1 year
measure: To determine if higher OT temperature range with IV Ondansetron (HO group) is superior to individual intervention alone in reducing the incidence of PSS
timeFrame: 1 year
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Center
Study officials:
affiliation: MALAYA UNIVERSITY
name: SIU MIN LIM, L
role: PRINCIPAL_INVESTIGATOR
affiliation: MALAYA UNIVERSITY
name: SOOK HUI CHAW, AP
role: STUDY_DIRECTOR
affiliation: MALAYA UNIVERSITY
name: CAROLYN YIM CHUE WAI, AP
role: STUDY_DIRECTOR
affiliation: MALAYA UNIVERSITY
name: JAUHARATUNNUR ISHAK, M
role: STUDY_CHAIR
affiliation: MALAYA UNIVERSITY
name: TSYR XIANG TEOH, M
role: STUDY_CHAIR
References:
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.
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.
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. doi: 10.1097/00000539-200202000-00034.
citation: Alfonsi P. Postanaesthetic shivering. Epidemiology, pathophysiology and approaches to prevention and management. Minerva Anestesiol. 2003 May;69(5):438-42.
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-2019-0006.