The Effect of Preoperative Warming on Postoperative Hypothermia

Perioperative Hypothermia Clinical Trial

Official title:

The Effect of Preoperative Warming on Postoperative Hypothermia in TURP Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01858727
• Other study ID #: ESM0606
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: October 2019
• Source: Ankara Diskapi Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypothermia
• Perioperative Hypothermia
• Preventing Hypothermia

Intervention

Other:
• forced air warming group
30 minutes before the preoperative will use forced air warming
• control group
do not heating group

Locations

Country	Name	City	State
Turkey	Diskapi Teaching and Research Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Diskapi Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess patient satisfaction	patient satisfaction scale (using a Likert scale type (range, 1 to 7) verbally administered questionnaire for patient satisfaction)	12 hours
Primary	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.	2-3 hours
Secondary	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.	2-3 hours
Secondary	Evaluation of hemodynamic variables (heart rate)	heart rate (HR) in beats per minute will be measured.	2-3 hours
Secondary	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.	2-3 hours