Ephedrine Usage and Hypothermia IncidenceNCT06245148
The Effect of Intraoperative Ephedrine Use on the Incidence of Hypothermia After Major Surgery
An observational study of Ephedrine Usage and Hypothermia Incidence and Effects of Ephedrine on Thermogulation, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Intraoperative hypothermia is a common and potentially severe complication during major surgical procedures. The consequences of intraoperative hypothermia can be far-reaching, affecting patient outcomes, recovery times, and overall healthcare costs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ephedrine Usage and Hypothermia Incidence, Effects of Ephedrine on Thermogulation
- What is being tested?
- Observation
- How many people
- 9,259 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2019to 30 Aug 2023
- How long will I take part?
- 1 Day
- 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: This observational study was conducted over a span of four years, from January 2020 to 2023,
Who may be able to join
- all adult patients (age 18 years) who received ephedrine during general anesthesia undergoing major surgical procedures
Who cannot join
- Patients undergoing minor surgical procedures
- Patients scheduled for day surgeries
- Patients patients (those under the age of 18)
- Patients with a history of thyroid disease
- Patients undergoing brain surgery
- Patients undergoing radiological interventions,
Show all 12Show fewer
- Trauma patients
- Patients directly transferred from the intensive care unit to the operating room
- Patients with preoperative fever (either low or high)
- Patients who have received vasoactive agents within 24 hours before surgery
- Patients with sepsis and/or septic shock, or fever within a week before surgery
- Patients who have received vasoactive agents
Trial locations and contacts
1 site in 1 country.
About this study
Intraoperative hypothermia is a common and potentially severe complication during major surgical procedures. The consequences of intraoperative hypothermia can be far-reaching, affecting patient outcomes, recovery times, and overall healthcare costs. Therefore, strategies aimed at preventing hypothermia are of paramount importance in modern surgical practice. However, despite all the measures taken, some patients may still become hypothermic at the end of surgery. Understanding these factors can enhance the quality of daily practice. Medications used intraoperatively can decrease the threshold for vasoconstriction, and some of them have been reported to influence thermoregulation. For example, ephedrine is a sympathomimetic amine used to maintain hemodynamic stability, but there is a report about its thermogenic effect. One study found that patients who received an intraoperative infusion of ephedrine had a significantly lower decrease in core temperature and these patients had a more stable hemodynamic profile. It was employed in obese patients for its thermogenic and appetite-suppressing effects until its adverse effects prevented its use. Ephedrine has an unintended yet significant effect on body temperature regulation, which has raised questions about its role in contributing to the incidence of hypothermia in the postoperative period. The purpose of this study is to investigate the potential relationship between the intraoperative use of ephedrine and the incidence of hypothermia following major surgery.
Read the detailed description
This study aims to investigate the potential relationship between the intraoperative use of ephedrine and the incidence of hypothermia following major surgery. The primary goal is to determine the effect of intraoperative ephedrine use on the incidence of hypothermia after major surgery. The secondary goal is to identify patient characteristics associated with an increased risk of hypothermia despite all measures taken. The results of this study could have important implications for the quality of care for patients undergoing major surgery.
- Being tested
- Observation
- Keywords
- Ephedrine usage, Intraoperative hypotension, Intraoperative hypothermia;, Major surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observation
| Study group | Role | What they receive |
|---|---|---|
| Hypothermia | Not described Receives: Other: Observation | |
| Normothermia | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Hypothermia after Major Surgery
The occurrence of hypothermia in patients who have undergone major surgery, specifically comparing those who received intraoperative ephedrine to those who did not.
Measured: From anesthesia induction until discharge to a ward, with the event defined as the time the patient meets all discharge criteria, assessed up to 10 hours post-operatively.
Secondary outcomes (1)
Patient Characteristics Associated with Increased Hypothermia Risk
Specific patient characteristics or factors that may increase the risk of hypothermia despite the implementation of measures to prevent it
Measured: From anesthesia induction until discharge to a ward, with the event defined as the time the patient meets all discharge criteria, assessed up to 10 hours post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start2 Jan 2019
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ephedrine Usage and Hypothermia IncidenceStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 9,259 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lerzan Doğan, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245148
- Sponsor's protocol ID
- 2023-14/506
- Status last verified
- Feb 2024
- First submitted
- 15 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Matsukawa T, Sessler DI, Sessler AM, Schroeder M, Ozaki M, Kurz A, Cheng C. Heat flow and distribution during induction of general anesthesia. Anesthesiology. 1995 Mar;82(3):662-73. doi: 10.1097/00000542-199503000-00008.
PubMed 7879935Flynn MD, Sandeman DD, Mawson DM, Shore AC, Tooke JE. Cyclical hypothermia: successful treatment with ephedrine. J R Soc Med. 1991 Dec;84(12):752-3. doi: 10.1177/014107689108401224. No abstract available.
PubMed 1774760Sarti A, Recanati D, Furlan S. Thermal regulation and intraoperative hypothermia. Minerva Anestesiol. 2005 Jun;71(6):379-83.
PubMed 15886605Im UJ, Lee DJ, Kim MC, Lee JS, Lee SJ. Difference in Core temperature in response to propofol-remifentanil anesthesia and sevoflurane-remifentanil anesthesia. Korean J Anesthesiol. 2009 Dec;57(6):704-708. doi: 10.4097/kjae.2009.57.6.704.
PubMed 30625952Nakasuji M, Nakamura M, Imanaka N, Tanaka M, Nomura M, Suh SH. Intraoperative high-dose remifentanil increases post-anaesthetic shivering. Br J Anaesth. 2010 Aug;105(2):162-7. doi: 10.1093/bja/aeq121. Epub 2010 Jun 10.
PubMed 20542888Jo YY, Kim JY, Kim JS, Kwon Y, Shin CS. The effect of ephedrine on intraoperative hypothermia. Korean J Anesthesiol. 2011 Apr;60(4):250-4. doi: 10.4097/kjae.2011.60.4.250. Epub 2011 Apr 26.
PubMed 21602974
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Ephedrine Use on the Incidence of Hypothermia After Major Surgery
- ClinicalTrials.gov ID
- NCT06245148
- Acronym / sponsor ID
- 2023-14/506
- Keywords
- Ephedrine usage, Intraoperative hypotension, Intraoperative hypothermia;, Major surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,259 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 7 Feb 2024 (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.
Intraoperative hypothermia is a common and potentially severe complication during major surgical procedures. The consequences of intraoperative hypothermia can be far-reaching, affecting patient outcomes, recovery times, and overall healthcare costs. Therefore, strategies aimed at preventing hypothermia are of paramount importance in modern surgical practice. However, despite all the measures taken, some patients may still become hypothermic at the end of surgery. Understanding these factors can enhance the quality of daily practice. Medications used intraoperatively can decrease the threshold for vasoconstriction, and some of them have been reported to influence thermoregulation. For example, ephedrine is a sympathomimetic amine used to maintain hemodynamic stability, but there is a report about its thermogenic effect. One study found that patients who received an intraoperative infusion of ephedrine had a significantly lower decrease in core temperature and these patients had a more stable hemodynamic profile. It was employed in obese patients for its thermogenic and appetite-suppressing effects until its adverse effects prevented its use. Ephedrine has an unintended yet significant effect on body temperature regulation, which has raised questions about its role in contributing to the incidence of hypothermia in the postoperative period. The purpose of this study is to investigate the potential relationship between the intraoperative use of ephedrine and the incidence of hypothermia following major surgery.
Detailed description
This study aims to investigate the potential relationship between the intraoperative use of ephedrine and the incidence of hypothermia following major surgery. The primary goal is to determine the effect of intraoperative ephedrine use on the incidence of hypothermia after major surgery. The secondary goal is to identify patient characteristics associated with an increased risk of hypothermia despite all measures taken. The results of this study could have important implications for the quality of care for patients undergoing major surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothermia | – | Other: Observation |
| Normothermia | – | Other: Observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational study was conducted over a span of four years, from January 2020 to 2023,
Key inclusion criteria (1 listed)
- all adult patients (age 18 years) who received ephedrine during general anesthesia undergoing major surgical procedures
Key exclusion criteria (12 listed)
- Patients undergoing minor surgical procedures
- Patients scheduled for day surgeries
- Patients patients (those under the age of 18)
- Patients with a history of thyroid disease
- Patients undergoing brain surgery
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 |
|---|---|---|
| ObservationObservation | Other | Hypothermia, Normothermia |
Primary outcome
Incidence of Hypothermia after Major Surgery
Time frame: From anesthesia induction until discharge to a ward, with the event defined as the time the patient meets all discharge criteria, assessed up to 10 hours post-operatively.
The occurrence of hypothermia in patients who have undergone major surgery, specifically comparing those who received intraoperative ephedrine to those who did not.
1 secondary outcome
Patient Characteristics Associated with Increased Hypothermia Risk
Time frame: From anesthesia induction until discharge to a ward, with the event defined as the time the patient meets all discharge criteria, assessed up to 10 hours post-operatively.
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 8 Feb 2024.
- Background: PubMed 7879935Matsukawa T, Sessler DI, Sessler AM, Schroeder M, Ozaki M, Kurz A, Cheng C. Heat flow and distribution during induction of general anesthesia. Anesthesiology. 1995 Mar;82(3):662-73. doi: 10.1097/00000542-199503000-00008.
- Background: PubMed 1774760Flynn MD, Sandeman DD, Mawson DM, Shore AC, Tooke JE. Cyclical hypothermia: successful treatment with ephedrine. J R Soc Med. 1991 Dec;84(12):752-3. doi: 10.1177/014107689108401224. No abstract available.
- Background: PubMed 15886605Sarti A, Recanati D, Furlan S. Thermal regulation and intraoperative hypothermia. Minerva Anestesiol. 2005 Jun;71(6):379-83.
- Background: PubMed 30625952Im UJ, Lee DJ, Kim MC, Lee JS, Lee SJ. Difference in Core temperature in response to propofol-remifentanil anesthesia and sevoflurane-remifentanil anesthesia. Korean J Anesthesiol. 2009 Dec;57(6):704-708. doi: 10.4097/kjae.2009.57.6.704.
- Background: PubMed 20542888Nakasuji M, Nakamura M, Imanaka N, Tanaka M, Nomura M, Suh SH. Intraoperative high-dose remifentanil increases post-anaesthetic shivering. Br J Anaesth. 2010 Aug;105(2):162-7. doi: 10.1093/bja/aeq121. Epub 2010 Jun 10.
- Results publication: PubMed 21602974Jo YY, Kim JY, Kim JS, Kwon Y, Shin CS. The effect of ephedrine on intraoperative hypothermia. Korean J Anesthesiol. 2011 Apr;60(4):250-4. doi: 10.4097/kjae.2011.60.4.250. Epub 2011 Apr 26.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ephedrine Usage and Hypothermia Incidence and Effects of Ephedrine on Thermogulation, run by Acibadem University at 1 site in Turkey (Türkiye).
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 1 inclusion and 12 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 8 Feb 2024. 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 Turkey (Türkiye). 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?
Incidence of Hypothermia after Major Surgery (time frame: From anesthesia induction until discharge to a ward, with the event defined as the time the patient meets all discharge criteria, assessed up to 10 hours post-operatively.). 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 NCT06245148, which also lists 6 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 8 Feb 2024.