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

NCT ID: NCT04654429

Last Updated: 2021-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

628 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-13

Study Completion Date

2022-12-30

Brief Summary

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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

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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.

Conditions

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Temperature Change, Body Chills Tremor Nausea, Postoperative Vomiting, Postoperative Postoperative Shivering

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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 Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lower OT temperature with placebo (LP)

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV Normal Saline 2cc will be given

Lower OT temperature Range

Intervention Type OTHER

OT temperature set to 17-19 degree celsius

Higher OT temperature with placebo (HP)

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.

Group Type ACTIVE_COMPARATOR

Higher OT temperature range

Intervention Type OTHER

OT temperature set to 19-22 degree celsius

Placebo

Intervention Type DRUG

IV Normal Saline 2cc will be given

Lower OT temperature with IV Ondansetron 4mg (LO)

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.

Group Type ACTIVE_COMPARATOR

IV Ondansetron 4mg

Intervention Type DRUG

IV ondansetron 4mg

Lower OT temperature Range

Intervention Type OTHER

OT temperature set to 17-19 degree celsius

higher OT temperature 19-22 and IV ondansetron 4mg (HO)

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.

Group Type ACTIVE_COMPARATOR

IV Ondansetron 4mg

Intervention Type DRUG

IV ondansetron 4mg

Higher OT temperature range

Intervention Type OTHER

OT temperature set to 19-22 degree celsius

Interventions

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IV Ondansetron 4mg

IV ondansetron 4mg

Intervention Type DRUG

Higher OT temperature range

OT temperature set to 19-22 degree celsius

Intervention Type OTHER

Placebo

IV Normal Saline 2cc will be given

Intervention Type DRUG

Lower OT temperature Range

OT temperature set to 17-19 degree celsius

Intervention Type OTHER

Other Intervention Names

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Pharmacological intervention Non-pharmacological intervention Control Control

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Dr Lim Siu Min

OTHER

Sponsor Role lead

Responsible Party

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Dr Lim Siu Min

Lecturer and Clinical Specialist

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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SIU MIN LIM, L

Role: PRINCIPAL_INVESTIGATOR

MALAYA UNIVERSITY

SOOK HUI CHAW, AP

Role: STUDY_DIRECTOR

MALAYA UNIVERSITY

CAROLYN YIM CHUE WAI, AP

Role: STUDY_DIRECTOR

MALAYA UNIVERSITY

JAUHARATUNNUR ISHAK, M

Role: STUDY_CHAIR

MALAYA UNIVERSITY

TSYR XIANG TEOH, M

Role: STUDY_CHAIR

MALAYA UNIVERSITY

Locations

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University Malaya Medical Center

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Countries

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Malaysia

Central Contacts

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SIU MIN LIM, L

Role: CONTACT

[email protected]
6017-7337750

Tsyr Xiang Teoh, M

Role: CONTACT

[email protected]
6017-4540608

Facility Contacts

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SIU MIN LIM, L

Role: primary

[email protected]
6017-7337750

Tsyr Xiang Teoh, M

Role: backup

[email protected]
6017-4540608

References

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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.

Reference Type RESULT
PMID: 18433676 (View on PubMed)

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.

Reference Type RESULT
PMID: 27622717 (View on PubMed)

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.

Reference Type RESULT
PMID: 11812709 (View on PubMed)

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

Reference Type RESULT
PMID: 12768180 (View on PubMed)

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.

Reference Type RESULT
PMID: 31111094 (View on PubMed)

Other Identifiers

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202073-8861

Identifier Type: OTHER

Identifier Source: secondary_id

NMRR-20-2158-56283

Identifier Type: -

Identifier Source: org_study_id