Comparison of the Effect of Prewarming on Intraoperative Hypothermia in Patients Undergoing Holmium Laser Prostatectomy

February 21, 2025 updated by: Betül Güven, Ankara City Hospital Bilkent

Comparison of the Effect of Prewarming on Intraoperative Hypothermia in Patients Undergoing HoLEP (Holmium Laser Prostatectomy) Surgery

This study aims to evaluate the effectiveness of prewarming methods in preventing intraoperative hypothermia in patients undergoing HoLEP surgery. Designed as a randomized controlled study, patients who receive prewarming will be compared with those in the control group.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey
      • Ankara, Turkey
        • Ankara City Hospital Bilkent

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

Yes

Description

Inclusion Criteria:

  • Male patients aged 18 years and older
  • Patients undergoing HoLEP surgery under general anesthesia
  • Patients who consent to participate in the study

Exclusion Criteria:

  • Patients who refuse to participate in the study.
  • Patients unable to read, understand, or sign the informed consent form.
  • Hemodynamically unstable patients.
  • Patients with a preoperative or intraoperative body temperature >37°C.

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prewarming Group
Patients will receive 10 minutes of 43°C forced-air warming and 41°C prewarmed intravenous fluid before surgery. Surgery will begin following the standard induction of general anesthesia once patients are in the operating room. An air blower set to 43°C will maintain patient warmth throughout the procedure.
Diagnostic test: intraoperative body temperature
Body temperature measurement with esophageal probe
Other: Control Group
No prewarming will be applied. Surgery will begin following the standard induction of general anesthesia once patients are in the operating room. An air blower set to 43°C will maintain patient warmth throughout the procedure.
Diagnostic test: intraoperative body temperature
Body temperature measurement with esophageal probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to onset of intraoperative hypothermia.
Time Frame: intraoperatively
Time to develop intraoperative hypothermia (when body temperature drops below 36°C)
intraoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic parameters
Time Frame: intraoperatively
heart rate
intraoperatively
Volume of irrigation fluid used
Time Frame: intraoperatively
Volume of irrigation fluid used
intraoperatively
Changes in body temperature
Time Frame: intraoperatively
Changes in preoperative and intraoperative body temperature
intraoperatively
Hemodynamic parameters
Time Frame: intraoperatively
mean arterial pressure
intraoperatively
respiratory parameter
Time Frame: intraoperatively
SpO2
intraoperatively

Collaborators and Investigators

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

Sponsor

Ankara City Hospital Bilkent

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 (Estimated)

March 1, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TABED1-24-841

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

product manufactured in and exported from the U.S.

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.

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