The Effect of Preoperative Warming on Postoperative Hypothermia

NCT ID: NCT01858727

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-07-01

Brief Summary

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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

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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.

Conditions

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Preventing Hypothermia Perioperative Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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forced air warming group

30 minutes before the preoperative will use forced air warming.

Group Type ACTIVE_COMPARATOR

forced air warming group

Intervention Type OTHER

30 minutes before the preoperative will use forced air warming

control group

Intervention Type OTHER

do not heating group

control group

do not active heating group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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forced air warming group

30 minutes before the preoperative will use forced air warming

Intervention Type OTHER

control group

do not heating group

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Diskapi Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fatma Kavak Akelma

Dr. fatma kavak akelma

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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fakelma 905327079113

Role: PRINCIPAL_INVESTIGATOR

Diskapi Teaching and Research Hospital

Locations

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Diskapi Teaching and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ESM0606

Identifier Type: -

Identifier Source: org_study_id

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