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

February 6, 2024 updated by: Lerzan Doğan, Acibadem University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

9259

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34662
        • Acibadem University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This observational study was conducted over a span of four years, from January 2020 to 2023,

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypothermia
Other: Observation
Observation
Normothermia
Other: Observation
Observation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Specific patient characteristics or factors that may increase the risk of hypothermia despite the implementation of measures to prevent it
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2019

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-14/506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ephedrine Usage and Hypothermia Incidence

Clinical Trials on Observation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe