Clinical trial NCT01858727: The Effect of Preoperative Warming on Postoperative Hypothermia
Official title: The Effect of Preoperative Warming on Postoperative Hypothermia in TURP Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preventing Hypothermia
Perioperative Hypothermia
Keywords: forced-air
hypothermia
TUR-P surgery
core temperatures
prewarming
general anaesthesia
Lead sponsor: Ankara Diskapi Training and Research Hospital
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 36
Sex: MALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Perioperative measurements of core temperature (centigrade ° C)
timeFrame: 2-3 hours
Secondary outcomes:
measure: Evaluation of hemodynamic variables (arterial blood pressure)
timeFrame: 2-3 hours
measure: Evaluation of hemodynamic variables (heart rate)
timeFrame: 2-3 hours
measure: Number of patients with postoperative shivering
timeFrame: 2-3 hours
Other outcomes:
measure: To assess patient satisfaction
timeFrame: 12 hours
Locations:
city: Ankara
country: Turkey
facility: Diskapi Teaching and Research Hospital
state: Altindag
Study officials:
affiliation: Diskapi Teaching and Research Hospital
name: fakelma 905327079113
role: PRINCIPAL_INVESTIGATOR
References: