Hypothermia Following AnesthesiaNCT04307095
Incidence of Postoperative Hypothermia and Associated Factors in Adult Patients Undergoing Surgery in Siriraj Hospital
An observational study of Hypothermia Following Anesthesia, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
Inadvertent postanesthetic hypothermia is unintentional drop in core body temperature <36C (96.8F) immediately following an operation, caused by multiple factors, and had lead to negative outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypothermia Following Anesthesia
- How many people
- 742 participants
- Where
- 1 siteThailand
- Study dates
- 16 Jan 2020to 15 Jan 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients of age more than 18 years old who undergoing anesthesia and surgery in Siriraj hospital.
Who may be able to join
- All patients >18 years undergoing surgery with anesthesia service
- Stay at Postanesthetic care unit of Syamindra building, fifth floor, Siriraj hospital
Who cannot join
- Procedure performed under local anesthesia
- Patients with missing data of temperature
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Siriraj Hospital, Faculty of medicine Siriraj hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
Inadvertent postanesthetic hypothermia is unintentional drop in core body temperature <36C (96.8F) immediately following an operation, caused by multiple factors, and had lead to negative outcomes. In our institute, a study in 2011 reported an incidence of postoperative hypothermia in PACU of 45.4% (95% CI 39.61%- 51.23%). After that, various interventions aimed to prevent perioperative hypothermia were implemented. This study is initiated to determine the incidence of postoperative hypothermia and associated factors of postoperative hypothermia in adult patients underwent surgery at Siriraj hospital.
Read the detailed description
Inadvertent postanesthetic hypothermia is unintentional drop in core body temperature <36C (96.8F) immediately following an operation, which is a common problem in post anesthesia care unit (PACU). It has been implicated in negative outcomes in surgical patients, including prolonged effects of intraoperative anesthetic medication, increased insulin resistance, postoperative morbidity, delayed surgical wound healing; and prolonged stay in the recovery room and hospital1-7.
In the operating room (OR), patients have to expose to a low ambient temperature with little or no clothing, evaporation from the surgical area, an irrigated fluid in surgical area; and an administration of intravenous fluids. Moreover, many anesthetic agents have an influence on the autonomic thermoregulatory mechanism which causes vasodilatation. All these factors promote patients' unintentional loss of heat and cause hypothermia.
Even of a lot of efforts to keep patients warm intraoperatively and minimize hypothermia including optimizing ambient OR temperature and using of various warming devices, the incidences of postoperative hypothermia in PACU are still high with the reported magnitude ranges from 50%- 90%7. In Siriraj hospital, a study in 2011 reported an incidence of postoperative hypothermia in PACU of 45.4% (95% CI 39.61%- 51.23%)8. After that, various interventions aimed to prevent perioperative hypothermia were implemented such as maintaining the ambient room temperature of an OR; warming intravenous fluids, blood products, and irrigants; heated, humidified anesthetic gases; and using warming blankets, forced-air warming, layering drapes and head wraps. This study is initiated to determine the incidence of postoperative hypothermia and associated factors of postoperative hypothermia in adult patients underwent surgery at Siriraj hospital.
- Conditions
- Hypothermia Following Anesthesia
- Keywords
- Postoperative hypothermia, Patient warming, Inadvertent hypothermia
What is being measured
The primary outcome is the main question the study is designed to answer.
Body temperature
Body temperature after admit in PACU
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start16 Jan 2020
- Primary completion1 Nov 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hypothermia Following AnesthesiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 742 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingkwan Wongyingsinn, MD, Siriraj Hospital
- Investigators
- Mingkwan Wongyingsinn, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307095
- Sponsor's protocol ID
- IRB889
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2020
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mauermann WJ, Nemergut EC. The anesthesiologist's role in the prevention of surgical site infections. Anesthesiology. 2006 Aug;105(2):413-21; quiz 439-40. doi: 10.1097/00000542-200608000-00025. No abstract available.
PubMed 16871076Panagiotis K, Maria P, Argiri P, Panagiotis S. Is postanesthesia care unit length of stay increased in hypothermic patients? AORN J. 2005 Feb;81(2):379-82, 385-92. doi: 10.1016/s0001-2092(06)60420-1.
PubMed 15768547Wartzek T, Muhlsteff J, Imhoff M. Temperature measurement. Biomed Tech (Berl). 2011 Oct;56(5):241-57. doi: 10.1515/BMT.2011.108.
PubMed 21988157Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
PubMed 18648241Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. doi: 10.1016/j.atc.2006.09.001.
PubMed 17342966Kiekkas P, Poulopoulou M, Papahatzi A, Souleles P. Effects of hypothermia and shivering on standard PACU monitoring of patients. AANA J. 2005 Feb;73(1):47-53.
PubMed 15727284Wongyingsinn M, Pookprayoon V. Incidence and associated factors of perioperative hypothermia in adult patients at a university-based, tertiary care hospital in Thailand. BMC Anesthesiol. 2023 Apr 25;23(1):137. doi: 10.1186/s12871-023-02084-2.
PubMed 37098492
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Hypothermia and Associated Factors in Adult Patients Undergoing Surgery in Siriraj Hospital
- ClinicalTrials.gov ID
- NCT04307095
- Acronym / sponsor ID
- IRB889
- Conditions
- Hypothermia Following Anesthesia
- Keywords
- Postoperative hypothermia, Patient warming, Inadvertent hypothermia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 742 participants (actual)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 13 Mar 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.
Inadvertent postanesthetic hypothermia is unintentional drop in core body temperature <36C (96.8F) immediately following an operation, caused by multiple factors, and had lead to negative outcomes. In our institute, a study in 2011 reported an incidence of postoperative hypothermia in PACU of 45.4% (95% CI 39.61%- 51.23%). After that, various interventions aimed to prevent perioperative hypothermia were implemented. This study is initiated to determine the incidence of postoperative hypothermia and associated factors of postoperative hypothermia in adult patients underwent surgery at Siriraj hospital.
Detailed description
Inadvertent postanesthetic hypothermia is unintentional drop in core body temperature <36C (96.8F) immediately following an operation, which is a common problem in post anesthesia care unit (PACU). It has been implicated in negative outcomes in surgical patients, including prolonged effects of intraoperative anesthetic medication, increased insulin resistance, postoperative morbidity, delayed surgical wound healing; and prolonged stay in the recovery room and hospital1-7.
In the operating room (OR), patients have to expose to a low ambient temperature with little or no clothing, evaporation from the surgical area, an irrigated fluid in surgical area; and an administration of intravenous fluids. Moreover, many anesthetic agents have an influence on the autonomic thermoregulatory mechanism which causes vasodilatation. All these factors promote patients' unintentional loss of heat and cause hypothermia.
Even of a lot of efforts to keep patients warm intraoperatively and minimize hypothermia including optimizing ambient OR temperature and using of various warming devices, the incidences of postoperative hypothermia in PACU are still high with the reported magnitude ranges from 50%- 90%7. In Siriraj hospital, a study in 2011 reported an incidence of postoperative hypothermia in PACU of 45.4% (95% CI 39.61%- 51.23%)8. After that, various interventions aimed to prevent perioperative hypothermia were implemented such as maintaining the ambient room temperature of an OR; warming intravenous fluids, blood products, and irrigants; heated, humidified anesthetic gases; and using warming blankets, forced-air warming, layering drapes and head wraps. This study is initiated to determine the incidence of postoperative hypothermia and associated factors of postoperative hypothermia in adult patients underwent surgery at Siriraj hospital.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients of age more than 18 years old who undergoing anesthesia and surgery in Siriraj hospital.
Key inclusion criteria (2 listed)
- All patients >18 years undergoing surgery with anesthesia service
- Stay at Postanesthetic care unit of Syamindra building, fifth floor, Siriraj hospital
Key exclusion criteria (2 listed)
- Procedure performed under local anesthesia
- Patients with missing data of temperature
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body temperature
Time frame: 1 min
Body temperature after admit in PACU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 16871076Mauermann WJ, Nemergut EC. The anesthesiologist's role in the prevention of surgical site infections. Anesthesiology. 2006 Aug;105(2):413-21; quiz 439-40. doi: 10.1097/00000542-200608000-00025. No abstract available.
- Background: PubMed 15768547Panagiotis K, Maria P, Argiri P, Panagiotis S. Is postanesthesia care unit length of stay increased in hypothermic patients? AORN J. 2005 Feb;81(2):379-82, 385-92. doi: 10.1016/s0001-2092(06)60420-1.
- Background: PubMed 21988157Wartzek T, Muhlsteff J, Imhoff M. Temperature measurement. Biomed Tech (Berl). 2011 Oct;56(5):241-57. doi: 10.1515/BMT.2011.108.
- Background: PubMed 18648241Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
- Background: PubMed 17342966Insler SR, Sessler DI. Perioperative thermoregulation and temperature monitoring. Anesthesiol Clin. 2006 Dec;24(4):823-37. doi: 10.1016/j.atc.2006.09.001.
- Background: PubMed 15727284Kiekkas P, Poulopoulou M, Papahatzi A, Souleles P. Effects of hypothermia and shivering on standard PACU monitoring of patients. AANA J. 2005 Feb;73(1):47-53.
- Derived from this study: PubMed 37098492Wongyingsinn M, Pookprayoon V. Incidence and associated factors of perioperative hypothermia in adult patients at a university-based, tertiary care hospital in Thailand. BMC Anesthesiol. 2023 Apr 25;23(1):137. doi: 10.1186/s12871-023-02084-2.
- Individual participant dataSharing planned: Undecided
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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.
Mingkwan Wongyingsinn, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia Following Anesthesia, run by Siriraj Hospital at 1 site in Thailand.
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 2 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: finished, as of the sponsor's last update on 10 Mar 2026. 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 Thailand. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature (time frame: 1 min). 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 NCT04307095, which also lists 7 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 10 Mar 2026.