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NCT Number: NCT01858727

The Effect of Preoperative Warming on Postoperative Hypothermia

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.

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Key information

Conditions

Preventing Hypothermia Body Temperature Changes Hypothermia Pathological Conditions, Signs and Symptoms Perioperative Hypothermia Signs and Symptoms

Age range

50 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Diskapi Teaching and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

forced air warming group

Other

30 minutes before the preoperative will use forced air warming

Control Group

Other

do not heating group

Primary outcomes

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

    Time frame: 2-3 hours

    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.

Secondary outcomes

  1. Evaluation of hemodynamic variables (arterial blood pressure)

    Time frame: 2-3 hours

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

  2. Evaluation of hemodynamic variables (heart rate)

    Time frame: 2-3 hours

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

  3. Number of patients with postoperative shivering

    Time frame: 2-3 hours

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

Other outcomes

  1. To assess patient satisfaction

    Time frame: 12 hours

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

Sponsors and collaborators

Lead sponsor

Ankara Diskapi Training and Research Hospital

Other

Registry information

Official study title

The Effect of Preoperative Warming on Postoperative Hypothermia in TURP Surgery

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 21, 2013
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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