PrewarmingNCT06847659
Comparison of the Effect of Prewarming on Intraoperative Hypothermia in Patients Undergoing Holmium Laser Prostatectomy
A study testing intraoperative body temperature in people with Prewarming and Holmium Laser Prostate Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prewarming, Holmium Laser Prostate Surgery, Hypothermia Following Anesthesia
- What is being tested?
- intraoperative body temperature
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male patients aged 18 years and older
- Patients undergoing HoLEP surgery under general anesthesia
- Patients who consent to participate in the study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Being tested
- intraoperative body temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative body temperatureDiagnostic test
Body temperature measurement with esophageal probe
| Study group | Role | What they receive |
|---|---|---|
| Prewarming Group | Experimental | 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. Receives: Diagnostic Test: intraoperative body temperature |
| Control Group | Other | 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. Receives: Diagnostic Test: intraoperative body temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of intraoperative hypothermia.
Time to develop intraoperative hypothermia (when body temperature drops below 36°C)
Measured: intraoperatively
Secondary outcomes (5)
Hemodynamic parameters
heart rate
Measured: intraoperatively
Volume of irrigation fluid used
Volume of irrigation fluid used
Measured: intraoperatively
Changes in body temperature
Changes in preoperative and intraoperative body temperature
Measured: intraoperatively
Hemodynamic parameters
mean arterial pressure
Measured: intraoperatively
respiratory parameter
SpO2
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrewarmingStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Güven, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847659
- Sponsor's protocol ID
- TABED1-24-841
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Prewarming on Intraoperative Hypothermia in Patients Undergoing HoLEP (Holmium Laser Prostatectomy) Surgery
- ClinicalTrials.gov ID
- NCT06847659
- Acronym / sponsor ID
- TABED1-24-841
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prewarming Group | Experimental | Diagnostic Test: intraoperative body temperaturePatients 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 | Other | Diagnostic Test: intraoperative body temperatureNo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male patients aged 18 years and older
- Patients undergoing HoLEP surgery under general anesthesia
- Patients who consent to participate in the study
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraoperative body temperatureBody temperature measurement with esophageal probe | Diagnostic test | Control Group, Prewarming Group |
Primary outcome
Time to onset of intraoperative hypothermia.
Time frame: intraoperatively
Time to develop intraoperative hypothermia (when body temperature drops below 36°C)
5 secondary outcomes
Hemodynamic parameters
Time frame: intraoperatively
Volume of irrigation fluid used
Time frame: intraoperatively
Changes in body temperature
Time frame: intraoperatively
Hemodynamic parameters
Time frame: intraoperatively
respiratory parameter
Time frame: intraoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Prewarming
Not yet recruiting
Effect of Prewarming Duration on Blood Flow After Colon Resection Surgery
Perioperative Hypothermia
RecruitingObservational study
Effect of Preoperative Prewarming on Serum Lactate Levels in Patients Undergoing Elective Nephrectomy
Nephrectomy / Methods, Intraoperative Hypothermia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intraoperative body temperature in people with Prewarming and Holmium Laser Prostate Surgery, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Betül Güven Aytaç, Assoc.prof. (+905073578351, drbguven@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to onset of intraoperative hypothermia. (time frame: intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.