The Effect of Preoperative Warming on Postoperative Hypothermia

NCT01858727 | Completed DMC

• 1 other identifier: ESM0606
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Preventing Hypothermia; Perioperative Hypothermia

Keywords

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

Outcome Measures

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.

  2-3 hours

Secondary Outcomes (3)

• Evaluation of hemodynamic variables (arterial blood pressure)

  2-3 hours

• Evaluation of hemodynamic variables (heart rate)

  2-3 hours

• Number of patients with postoperative shivering

  2-3 hours

Other Outcomes (1)

• To assess patient satisfaction

  12 hours

Study Arms (2)

forced air warming group

ACTIVE COMPARATOR

30 minutes before the preoperative will use forced air warming.

Other: forced air warming group; Other: control group

control group

NO INTERVENTION

do not active heating group

Interventions

forced air warming group OTHER

30 minutes before the preoperative will use forced air warming

forced air warming group

control group OTHER

do not heating group

forced air warming group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ankara Diskapi Training and Research Hospital: lead

Study Sites (1)

Diskapi Teaching and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• fakelma 905327079113

  Diskapi Teaching and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. fatma kavak akelma

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 21, 2013
• Study Start: November 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 8, 2019

Record last verified: 2019-10

Locations

TU (1)