The Effect of Intraoperative Ephedrine Use on the Incidence of Hypothermia After Major Surgery

NCT ID: NCT06245148

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9259 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-02

Study Completion Date

2023-08-30

Brief Summary

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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

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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.

Conditions

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Ephedrine Usage and Hypothermia Incidence Effects of Ephedrine on Thermogulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Hypothermia

Observation

Intervention Type OTHER

Observation

Normothermia

Observation

Intervention Type OTHER

Observation

Interventions

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Observation

Observation

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* all adult patients (age 18 years) who received ephedrine during general anesthesia undergoing major surgical procedures

Exclusion Criteria

* 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,
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Lerzan Doğan

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Acibadem University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 7879935 (View on PubMed)

Flynn 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.

Reference Type BACKGROUND
PMID: 1774760 (View on PubMed)

Sarti A, Recanati D, Furlan S. Thermal regulation and intraoperative hypothermia. Minerva Anestesiol. 2005 Jun;71(6):379-83.

Reference Type BACKGROUND
PMID: 15886605 (View on PubMed)

Im 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.

Reference Type BACKGROUND
PMID: 30625952 (View on PubMed)

Nakasuji 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.

Reference Type BACKGROUND
PMID: 20542888 (View on PubMed)

Jo 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.

Reference Type RESULT
PMID: 21602974 (View on PubMed)

Other Identifiers

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2023-14/506

Identifier Type: -

Identifier Source: org_study_id

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