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CompletedNCT01858727Updated Oct 8, 2019

The Effect of Preoperative Warming on Postoperative Hypothermia

An interventional study of forced air warming group and control group in Preventing Hypothermia and Perioperative Hypothermia, sponsored by Ankara Diskapi Training and Research Hospital. Completed at 1 site in Turkey. Open to male participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-08.

Sponsored by Ankara Diskapi Training and Research Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
Male
01

Study summary

36 patients American society of anesthesiology (ASA) physical status I,II and III undergoing general anesthesia for elective transurethral resection of the prostate (TUR-P) surgery will be included in the study. Patients will be randomized into two groups; first group(control group) and second group (forced-air warming). Resistive heating will start when patients are transferred to the operating room table; forced-air warming will start before preoperative 30 minute.

Read the detailed description

The primary aim of this study was to compare the effect of prewarming on perioperative hypothermia in elderly patients undergoing TURP under general anesthesia. In addition, we aimed to evaluate the effects of prewarming on hemodynamic variables, PACU output time, tremor, patient comfort and satisfaction. The investigators plan to enroll 36 patients in 2 groups. Body temperature will be measured at the core temperature, hemodynamic variables. Shivering will be graded by visual inspection. Thermal discomfort scale, patient satisfaction will be evaluated. The investigators hypothesize will decrease the forced air prewarming incidence of perioperative hypothermia.

02

Conditions studied

  • Preventing Hypothermia
  • Perioperative Hypothermia

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Keywords

  • forced-air
  • hypothermia
  • TUR-P surgery
  • core temperatures
  • prewarming
  • general anaesthesia
03

In context

Hypothermia

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

This study's enrollment of 36 is below the median of 80 across 351 interventional studies indexed under Hypothermia.

Browse Hypothermia studies →

Lead sponsor

Ankara Diskapi Training and Research Hospital is the lead sponsor of 19 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients aged 50-85 years undergoing general anesthesia for TURP surgery
  • ASA physical status I and III patients
  • Body mass index between 15 and 36 kg/m2
  • General anesthesia time is 30-90 minutes

Exclusion criteria

Exclusion Criteria:

  • without written consent,
  • inadequate Turkish comprehension,
  • known impaired thermoregulation or thyroid disorders,
  • severe hypertension (systolic blood pressure [SBP]>180 mmHg or diastolic blood pressure [DBP] > 110 mmHg in the operating suite admission),
  • an angiotensin-converting enzyme inhibitor/angiotensin II receptor antagonist on the day of surgery,
  • secondary hypertension (e.g., renal artery stenosis, pheochromocytoma, Cushing's syndrome),
  • vascular disease,
  • poor cutaneous perfusion,
  • serious skin lesions
  • baseline temperature ≥37.5°C (degrees centigrade)
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    forced air warming group

    30 minutes before the preoperative will use forced air warming.

    Other: forced air warming group · Other: control group

  • No intervention
    control group

    do not active heating group

Interventions

  • Otherforced air warming group

    30 minutes before the preoperative will use forced air warming

  • Othercontrol group

    do not heating group

06

What researchers measure

Primary outcomes

  1. Perioperative measurements of core temperature (centigrade ° C)

    After the operation patients will be admitted to the PACU. Here, body temperature will be assessed and the incidence of hypothermic patients (body temperature \< 36°C)will be measured.

    Time frame: 2-3 hours

Secondary outcomes

  1. Evaluation of hemodynamic variables (arterial blood pressure)

    systolic blood pressure (SBP) in mmHg, diastolic blood pressure (DBP) in mmHg, mean arterial pressure (MAP) in mmHg will be measured.

    Time frame: 2-3 hours

  2. Evaluation of hemodynamic variables (heart rate)

    heart rate (HR) in beats per minute will be measured.

    Time frame: 2-3 hours

  3. Number of patients with postoperative shivering

    After the operation patients will be admitted to the PACU. Here, postoperative shivering will be measured and graded by visual inspection.

    Time frame: 2-3 hours

Other outcomes

  1. To assess patient satisfaction

    patient satisfaction scale (using a Likert scale type (range, 1 to 7) verbally administered questionnaire for patient satisfaction)

    Time frame: 12 hours

07

Study locations

1 site
  • Diskapi Teaching and Research Hospital
    Ankara, Altindag, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01858727
Lead sponsor
Ankara Diskapi Training and Research Hospital
Responsible party
Fatma Kavak Akelma (Dr. fatma kavak akelma, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital) — Principal investigator
First posted
May 21, 2013
Start date
Nov 1, 2018
Primary completion
Feb 1, 2019
Completion
Jul 1, 2019
Last update
Oct 8, 2019

Study contacts

fakelma 905327079113
principal investigator · Diskapi Teaching and Research Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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