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

NCT06245148 | Completed

• 1 other identifier: 2023-14/506
• Study Type: observational
• Target: 9,259
• Locations: 1 country
• Sites: 1

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.

Conditions

Ephedrine Usage and Hypothermia Incidence; Effects of Ephedrine on Thermogulation

Keywords

Ephedrine usage; Intraoperative hypotension; Intraoperative hypothermia;; Major surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

Study Arms (2)

Hypothermia

Other: Observation

Normothermia

Other: Observation

Interventions

Observation OTHER

Observation

Hypothermia; Normothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem University

Istanbul, 34662, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 7879935 BACKGROUND

• 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.

  PMID: 1774760 BACKGROUND

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

  PMID: 15886605 BACKGROUND

• 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.

  PMID: 30625952 BACKGROUND

• 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.

  PMID: 20542888 BACKGROUND

• 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.

  PMID: 21602974 RESULT

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 7, 2024
• Study Start: January 2, 2019
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

TU (1)