Comparison of the Effect of Prewarming on Intraoperative Hypothermia in Patients Undergoing Holmium Laser Prostatectomy
1 other identifier
interventional
106
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2025
CompletedFirst Posted
Study publicly available on registry
February 26, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2025
CompletedFebruary 26, 2025
February 1, 2025
4 months
February 18, 2025
February 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Time to onset of intraoperative hypothermia.
Time to develop intraoperative hypothermia (when body temperature drops below 36°C)
intraoperatively
Secondary Outcomes (5)
Hemodynamic parameters
intraoperatively
Volume of irrigation fluid used
intraoperatively
Changes in body temperature
intraoperatively
Hemodynamic parameters
intraoperatively
respiratory parameter
intraoperatively
Study Arms (2)
Prewarming Group
EXPERIMENTALPatients 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.
Control Group
OTHERNo 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.
Interventions
Body temperature measurement with esophageal probe
Eligibility Criteria
You may qualify if:
- Male patients aged 18 years and older
- Patients undergoing HoLEP surgery under general anesthesia
- Patients who consent to participate in the study
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara City Hospital Bilkent
Ankara, Turkey (Türkiye)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ankara City Hospital Bilkent
Study Record Dates
First Submitted
February 18, 2025
First Posted
February 26, 2025
Study Start
March 1, 2025
Primary Completion
June 30, 2025
Study Completion
August 31, 2025
Last Updated
February 26, 2025
Record last verified: 2025-02