ClinicalTrials.gg
Not yet recruitingNCT06847659Updated Feb 26, 2025

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

An interventional study of intraoperative body temperature in Prewarming, Holmium Laser Prostate Surgery and Hypothermia Following Anesthesia, sponsored by Ankara City Hospital Bilkent. Not yet recruiting at 1 site in Turkey. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-26.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Prewarming
  • Holmium Laser Prostate Surgery
  • Hypothermia Following Anesthesia

Browse trials for

03

In context

Hypothermia

449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.

This study's planned enrollment of 106 is above the median of 77 across 328 interventional studies indexed under Hypothermia.

Browse Hypothermia studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients who refuse to participate in the study.
  • Patients unable to read, understand, or sign the form.
  • Hemodynamically unstable patients.
  • Patients with a preoperative or intraoperative body temperature >37°C.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
106 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Diagnostic testintraoperative body temperature

    Body temperature measurement with esophageal probe

06

What researchers measure

Primary outcomes

  1. Time to onset of intraoperative hypothermia.

    Time to develop intraoperative hypothermia (when body temperature drops below 36°C)

    Time frame: intraoperatively

Secondary outcomes

  1. Hemodynamic parameters

    heart rate

    Time frame: intraoperatively

  2. Volume of irrigation fluid used

    Volume of irrigation fluid used

    Time frame: intraoperatively

  3. Changes in body temperature

    Changes in preoperative and intraoperative body temperature

    Time frame: intraoperatively

  4. Hemodynamic parameters

    mean arterial pressure

    Time frame: intraoperatively

  5. respiratory parameter

    SpO2

    Time frame: intraoperatively

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06847659
Responsible party
Betül Güven (Ankara City Hospital Bilkent, Ankara City Hospital Bilkent) — Principal investigator
First posted
Feb 26, 2025
Start date
Mar 1, 2025 (estimated)
Primary completion
Jun 30, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Feb 26, 2025

Study contacts

Betül Güven Aytaç, Assoc.prof.
Contact
drbguven@hotmail.com
+905073578351

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion