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

NCT ID: NCT06847659

Last Updated: 2025-02-26

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prewarming Holmium Laser Prostate Surgery Hypothermia Following Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

intraoperative body temperature

Intervention Type DIAGNOSTIC_TEST

Body temperature measurement with esophageal probe

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.

Group Type OTHER

intraoperative body temperature

Intervention Type DIAGNOSTIC_TEST

Body temperature measurement with esophageal probe

Interventions

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intraoperative body temperature

Body temperature measurement with esophageal probe

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Betül Güven

Ankara City Hospital Bilkent

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara City Hospital Bilkent

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Betül Güven Aytaç, Assoc.prof.

Role: CONTACT

+905073578351

Other Identifiers

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TABED1-24-841

Identifier Type: -

Identifier Source: org_study_id

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