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

NCT04654429 | Unknown Phase 4 DMC

• 2 other identifiers: NMRR-20-2158-56283202073-8861
• Study Type: interventional
• Target: 628
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• To determine the incidence of PSS

  1 year

• To determine the average threshold body temperature, ⁰C at which shivering occur.

  1 year

• To determine the change in body temperature (mean δ Temp ⁰C) at which shivering occur

  1 year

• To determine if higher OT temperature range with IV Ondansetron (HO group) is superior to individual intervention alone in reducing the incidence of PSS

  1 year

Study Arms (4)

Lower OT temperature with placebo (LP)

PLACEBO COMPARATOR

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.

Drug: Placebo; Other: Lower OT temperature Range

Higher OT temperature with placebo (HP)

ACTIVE COMPARATOR

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.

Other: Higher OT temperature range; Drug: Placebo

Lower OT temperature with IV Ondansetron 4mg (LO)

ACTIVE COMPARATOR

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.

Drug: IV Ondansetron 4mg; Other: Lower OT temperature Range

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

ACTIVE COMPARATOR

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.

Drug: IV Ondansetron 4mg; Other: Higher OT temperature range

Interventions

IV Ondansetron 4mg DRUG

IV ondansetron 4mg

Also known as: Pharmacological intervention

Lower OT temperature with IV Ondansetron 4mg (LO); higher OT temperature 19-22 and IV ondansetron 4mg (HO)

Higher OT temperature range OTHER

OT temperature set to 19-22 degree celsius

Also known as: Non-pharmacological intervention

Higher OT temperature with placebo (HP); higher OT temperature 19-22 and IV ondansetron 4mg (HO)

Placebo DRUG

IV Normal Saline 2cc will be given

Also known as: Control

Higher OT temperature with placebo (HP); Lower OT temperature with placebo (LP)

Lower OT temperature Range OTHER

OT temperature set to 17-19 degree celsius

Also known as: Control

Lower OT temperature with IV Ondansetron 4mg (LO); Lower OT temperature with placebo (LP)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Parturients going for lower segment cesarean section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Lim Siu Min: lead

Study Sites (1)

University Malaya Medical Center

Kuala Lumpur, 50603, Malaysia

RECRUITING

Related Publications (5)

• 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.

  PMID: 18433676 RESULT

• 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.

  PMID: 27622717 RESULT

• 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.

  PMID: 11812709 RESULT

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

  PMID: 12768180 RESULT

• 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.

  PMID: 31111094 RESULT

MeSH Terms

Conditions

Body Temperature Changes; Chills; Tremor; Postoperative Nausea and Vomiting

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• SIU MIN LIM, L

  MALAYA UNIVERSITY

  PRINCIPAL INVESTIGATOR

• SOOK HUI CHAW, AP

  MALAYA UNIVERSITY

  STUDY DIRECTOR

• CAROLYN YIM CHUE WAI, AP

  MALAYA UNIVERSITY

  STUDY DIRECTOR

• JAUHARATUNNUR ISHAK, M

  MALAYA UNIVERSITY

  STUDY CHAIR

• TSYR XIANG TEOH, M

  MALAYA UNIVERSITY

  STUDY CHAIR

Central Study Contacts

SIU MIN LIM, L

CONTACT

6017-7337750; limsiumin@gmail.com

Tsyr Xiang Teoh, M

CONTACT

6017-4540608; tsyrxiang@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer and Clinical Specialist

Model Details: 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.

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: December 4, 2020
• Study Start: October 13, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)