Temperature Change, BodyPhase 4HOTONNCT04654429
Does Higher OT Temperature and IV Ondansetron Reduce Incidence of PSS in Parturients?
A Phase 4 study testing IV Ondansetron 4mg, Higher OT temperature range and Lower OT temperature Range in people with Temperature Change, Body and Chills, run by Dr Lim Siu Min at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Temperature Change, Body, Chills, Tremor
- What is being tested?
- IV Ondansetron 4mg, Higher OT temperature range and Lower OT temperature Range
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 628 participants
- Where
- 1 siteMalaysia
- Study dates
- 13 Oct 2020to 30 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Center
Kuala Lumpur, 50603
SIU MIN LIM, L, 6017-7337750, limsiumin@gmail.com
Tsyr Xiang Teoh, M, 6017-4540608, tsyrxiang@gmail.com
About this study
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.
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.
Read the 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.
- Conditions
- Temperature Change, Body, Chills, Tremor, Nausea, Postoperative, Vomiting, Postoperative, Postoperative Shivering
- Being tested
- IV Ondansetron 4mg, Higher OT temperature range, Placebo, Lower OT temperature Range
- Keywords
- Post-spinal shivering, Subarachnoid block, obstetrics, caesarean section, temperature, ondansetron, factorial study
- Medical subject headings
- Body Temperature Changes, Chills, Tremor, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Ondansetron 4mgDrug
Also called Pharmacological intervention
IV ondansetron 4mg
Higher OT temperature rangeOther
Also called Non-pharmacological intervention
OT temperature set to 19-22 degree celsius
PlaceboDrug
Also called Control
IV Normal Saline 2cc will be given
Lower OT temperature RangeOther
Also called Control
OT temperature set to 17-19 degree celsius
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: IV Ondansetron 4mg; Other: Higher OT temperature range |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 year
Secondary outcomes (4)
To determine the incidence of PSS
Number patients of with shivering grade 3 and above.
Measured: 1 year
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
Measured: 1 year
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
Measured: 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
Assessment of patient's shivering grade according to Crossley and Mahajan classification
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start13 Oct 2020
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 628 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Lim Siu Min
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Lim Siu Min, University of Malaya
- Investigators
- SIU MIN LIM, L, Principal investigator, MALAYA UNIVERSITYSOOK HUI CHAW, AP, Study director, MALAYA UNIVERSITYCAROLYN YIM CHUE WAI, AP, Study director, MALAYA UNIVERSITYJAUHARATUNNUR ISHAK, M, Study chair, MALAYA UNIVERSITYTSYR XIANG TEOH, M, Study chair, MALAYA UNIVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654429
- Sponsor's protocol ID
- NMRR-20-2158-56283
- Other IDs
- 202073-8861
- Acronym
- HOTON
- Status last verified
- Oct 2021
- First submitted
- 11 Nov 2020
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 18433676Choi 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.
PubMed 27622717Horn 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.
PubMed 11812709Alfonsi P. Postanaesthetic shivering. Epidemiology, pathophysiology and approaches to prevention and management. Minerva Anestesiol. 2003 May;69(5):438-42.
PubMed 12768180Varshney 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.
PubMed 31111094
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04654429
- Acronym / sponsor ID
- HOTON / NMRR-20-2158-56283
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 628 participants (estimated)
- Lead sponsor
- Dr Lim Siu MinUniversity, hospital or other
- Study start
- 13 Oct 2020 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lower OT temperature with placebo (LP) | Placebo comparator | Drug: Placebo, Other: Lower OT temperature RangeLower 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 (HP) | Active comparator | Other: Higher OT temperature range, Drug: PlaceboHigher 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 IV Ondansetron 4mg (LO) | Active comparator | Drug: IV Ondansetron 4mg, Other: Lower OT temperature RangeLower 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. |
| higher OT temperature 19-22 and IV ondansetron 4mg (HO) | Active comparator | Drug: IV Ondansetron 4mg, Other: Higher OT temperature rangeThis 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV Ondansetron 4mgAlso: Pharmacological interventionIV ondansetron 4mg | Drug | Lower OT temperature with IV Ondansetron 4mg (LO), higher OT temperature 19-22 and IV ondansetron 4mg (HO) |
| Higher OT temperature rangeAlso: Non-pharmacological interventionOT temperature set to 19-22 degree celsius | Other | Higher OT temperature with placebo (HP), higher OT temperature 19-22 and IV ondansetron 4mg (HO) |
| PlaceboAlso: ControlIV Normal Saline 2cc will be given | Drug | Higher OT temperature with placebo (HP), Lower OT temperature with placebo (LP) |
| Lower OT temperature RangeAlso: ControlOT temperature set to 17-19 degree celsius | Other | Lower OT temperature with IV Ondansetron 4mg (LO), Lower OT temperature with placebo (LP) |
Primary outcome
To Demonstrate higher OT temperature range ( 19.1- 22.0 degree Celcius) is effective in reducing the incidence PSS in parturients.
Time frame: 1 year
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.
Time frame: 1 year
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
4 secondary outcomes
To determine the incidence of PSS
Time frame: 1 year
To determine the average threshold body temperature, ⁰C at which shivering occur.
Time frame: 1 year
To determine the change in body temperature (mean δ Temp ⁰C) at which shivering occur
Time frame: 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
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Results publication: PubMed 18433676Crowley 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 publication: PubMed 27622717Choi 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 publication: PubMed 11812709Horn 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 publication: PubMed 12768180Alfonsi P. Postanaesthetic shivering. Epidemiology, pathophysiology and approaches to prevention and management. Minerva Anestesiol. 2003 May;69(5):438-42.
- Results publication: PubMed 31111094Varshney 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SIU MIN LIM, L principal investigator
MALAYA UNIVERSITY
SOOK HUI CHAW, AP study director
MALAYA UNIVERSITY
CAROLYN YIM CHUE WAI, AP study director
MALAYA UNIVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV Ondansetron 4mg, Higher OT temperature range and Lower OT temperature Range in people with Temperature Change, Body and Chills, run by Dr Lim Siu Min at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SIU MIN LIM, L (6017-7337750, limsiumin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Demonstrate higher OT temperature range ( 19.1- 22.0 degree Celcius) is effective in reducing the incidence PSS in parturients. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04654429, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.