The Effect of Preoperative Warming on Postoperative Hypothermia

The Effect of Preoperative Warming on Postoperative Hypothermia in TURP Surgery

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.

Study Overview

• Status: Completed
• Conditions: Preventing Hypothermia; Perioperative Hypothermia
• Intervention / Treatment: Other: forced air warming group; Other: control group

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Altindag
    • Ankara, Altindag, Turkey
      • Diskapi Teaching and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: forced air warming group; 30 minutes before the preoperative will use forced air warming.	Other: forced air warming group; 30 minutes before the preoperative will use forced air warming; Other: control group; do not heating group
No Intervention: control group; do not active heating group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Evaluation of hemodynamic variables (heart rate)	heart rate (HR) in beats per minute will be measured.	2-3 hours
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess patient satisfaction	patient satisfaction scale (using a Likert scale type (range, 1 to 7) verbally administered questionnaire for patient satisfaction)	12 hours

Collaborators and Investigators

• Sponsor: Ankara Diskapi Training and Research Hospital
• Investigators: Principal Investigator: fakelma 905327079113, Diskapi Teaching and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: May 13, 2013
• First Submitted That Met QC Criteria: May 20, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 5, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: general anaesthesia; hypothermia; prewarming; forced-air; TUR-P surgery; core temperatures
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: ESM0606

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No