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

Primary Purpose

Temperature Change, Body, Chills, Tremor

Status
Unknown status
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
IV Ondansetron 4mg
Higher OT temperature range
Placebo
Lower OT temperature Range
Sponsored by
Dr Lim Siu Min
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Temperature Change, Body focused on measuring Post-spinal shivering, Subarachnoid block, obstetrics, caesarean section, temperature, ondansetron, factorial study

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University Malaya Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lower OT temperature with placebo (LP)

Higher OT temperature with placebo (HP)

Lower OT temperature with IV Ondansetron 4mg (LO)

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

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

To determine the incidence of PSS
Number patients of with shivering grade 3 and above.
To determine the average threshold body temperature, ⁰C 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
To determine the change in body temperature (mean δ Temp ⁰C) at which shivering occur
To assess average temperature drop in order for shivering to occur from linear graph
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

Full Information

First Posted
November 11, 2020
Last Updated
October 12, 2021
Sponsor
Dr Lim Siu Min
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1. Study Identification

Unique Protocol Identification Number
NCT04654429
Brief Title
Does Higher OT Temperature and IV Ondansetron Reduce Incidence of PSS in Parturients?
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr Lim Siu Min

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temperature Change, Body, Chills, Tremor, Nausea, Postoperative, Vomiting, Postoperative, Postoperative Shivering
Keywords
Post-spinal shivering, Subarachnoid block, obstetrics, caesarean section, temperature, ondansetron, factorial study

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
628 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lower OT temperature with placebo (LP)
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Higher OT temperature with placebo (HP)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lower OT temperature with IV Ondansetron 4mg (LO)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
higher OT temperature 19-22 and IV ondansetron 4mg (HO)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IV Ondansetron 4mg
Other Intervention Name(s)
Pharmacological intervention
Intervention Description
IV ondansetron 4mg
Intervention Type
Other
Intervention Name(s)
Higher OT temperature range
Other Intervention Name(s)
Non-pharmacological intervention
Intervention Description
OT temperature set to 19-22 degree celsius
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
IV Normal Saline 2cc will be given
Intervention Type
Other
Intervention Name(s)
Lower OT temperature Range
Other Intervention Name(s)
Control
Intervention Description
OT temperature set to 17-19 degree celsius
Primary Outcome Measure Information:
Title
To Demonstrate higher OT temperature range ( 19.1- 22.0 degree Celcius) is effective in reducing the incidence PSS in parturients.
Description
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
Time Frame
1 year
Title
To demonstrate IV Ondansetron is effective in reducing the incidence of PSS in parturient undergoing LSCS.
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To determine the incidence of PSS
Description
Number patients of with shivering grade 3 and above.
Time Frame
1 year
Title
To determine the average threshold body temperature, ⁰C at which shivering occur.
Description
To determine the average range of temperature that grade 3 and above shivering occurred among the recruited population from linear graph
Time Frame
1 year
Title
To determine the change in body temperature (mean δ Temp ⁰C) at which shivering occur
Description
To assess average temperature drop in order for shivering to occur from linear graph
Time Frame
1 year
Title
To determine if higher OT temperature range with IV Ondansetron (HO group) is superior to individual intervention alone in reducing the incidence of PSS
Description
Assessment of patient's shivering grade according to Crossley and Mahajan classification
Time Frame
1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Parturients going for lower segment cesarean section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SIU MIN LIM, L
Phone
6017-7337750
Email
limsiumin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tsyr Xiang Teoh, M
Phone
6017-4540608
Email
tsyrxiang@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SIU MIN LIM, L
Organizational Affiliation
MALAYA UNIVERSITY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
SOOK HUI CHAW, AP
Organizational Affiliation
MALAYA UNIVERSITY
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
CAROLYN YIM CHUE WAI, AP
Organizational Affiliation
MALAYA UNIVERSITY
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
JAUHARATUNNUR ISHAK, M
Organizational Affiliation
MALAYA UNIVERSITY
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
TSYR XIANG TEOH, M
Organizational Affiliation
MALAYA UNIVERSITY
Official's Role
Study Chair
Facility Information:
Facility Name
University Malaya Medical Center
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SIU MIN LIM, L
Phone
6017-7337750
Email
limsiumin@gmail.com
First Name & Middle Initial & Last Name & Degree
Tsyr Xiang Teoh, M
Phone
6017-4540608
Email
tsyrxiang@gmail.com
First Name & Middle Initial & Last Name & Degree
SIU MIN LIM, L
First Name & Middle Initial & Last Name & Degree
SOOK HUI CHAW, AP
First Name & Middle Initial & Last Name & Degree
CAROLYN YIM CHUE WAI, AP
First Name & Middle Initial & Last Name & Degree
JAUHARATUNNUR ISHAK, M
First Name & Middle Initial & Last Name & Degree
TSYR XIANG TEOH, M

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All volunteers identity will be kept anonymous. However demographic data, body biometrics, underlying co-morbidities, indications for cesarean section, and study outcomes will be analysed and tabulated for publication purposes.
Citations:
PubMed Identifier
18433676
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.
Results Reference
result
PubMed Identifier
27622717
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.
Results Reference
result
PubMed Identifier
11812709
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.
Results Reference
result
PubMed Identifier
12768180
Citation
Alfonsi P. Postanaesthetic shivering. Epidemiology, pathophysiology and approaches to prevention and management. Minerva Anestesiol. 2003 May;69(5):438-42.
Results Reference
result
PubMed Identifier
31111094
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.
Results Reference
result

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

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