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

Completed

• Conditions: Ephedrine Usage and Hypothermia Incidence; Effects of Ephedrine on Thermogulation

• Registration Number: NCT06245148
• Lead Sponsor: Acibadem University

Brief 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. 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 Timeline

• Study Start: 2019-01-02
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9259

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Hypothermia after Major Surgery	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.

Secondary Outcome Measures

Name	Time	Method
Patient Characteristics Associated with Increased Hypothermia Risk	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

Trial Locations

Locations (1)

Acibadem University; 🇹🇷 Istanbul, Turkey