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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05636189
Other study ID # 2022-08-011-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date August 8, 2023

Study information

Verified date August 2023
Source Inje University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hypothermia occurs frequently during general anesthesia. This study is to evaluate the efficacy of 10 minutes of prewarming during induction of general anesthesia during urologic surgery.


Description:

Hypothermia is of continuous issue in patients undergoing general anesthesia. During urologic operation (transurethral resection of bladder and prostate), bladder irrigation worsens hypothermia. Hence, various methods including prewarming of the patient are used to maintain core temperature during operation. Prewarming is found to be effective in maintaining core temperature perioperatively by increasing peripheral tissue heat content. However, applying more than 30 minutes of prewarming may be impractical as a clinical routine practice. Hence, developing simple and effective method to prevent hypothermia is expected. Here, the investigators planned to examine the effect of active warming (10 minutes of warming during induction of general anesthesia and prewarmed intravenous fluid intraoperatively) on hypothermia in patients undergoing urologic operation under general anesthesia.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 8, 2023
Est. primary completion date August 8, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria: - patients undergoing urologic surgery(transurethral resection of bladder, prostate) Exclusion Criteria: - moderate to severe cardiopulmonary, renal impairment - previous thyroid disease - any infection sign - abnormal temperature prior to induction of general anesthesia (<36'C or >37.5'C) - refusal to participate in the study - unable to understand the study

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
warming during induction of anesthesia
Warming group patients are applied air-forced warming device (bair-hugger 43'C) with blanket (warm touch, COVIDIEN, full body blanket) during induction of anesthesia in the operation room.
Prewarmed intravenous fluid administration
Prewarmed intravenous fluid is connected.

Locations

Country Name City State
Korea, Republic of Sanggye paik hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary incidence of hypothermia at the end of the operation number of patients with hypothermia (<36'C) using esophageal stethoscope will be recorded. approximately 1-2hours after induction (at the end of operation)
Secondary change in temperature drop before and end of operation change in core temperature will be observed on arrival at the OR upto 1-2hours after induction (at the end of the operation)
Secondary thermal comfort thermal comfort scale ( 0= very cold, 5= fine, 10= very hot and uncomfortable) will be used. upto 1hour after end of the operation (at discharge of postanesthesia care unit)
Secondary incidence of shivering 4 point shivering scale (0=none, 1=core and neck shivering, 2= upper extremity 3= whole body) will be used. upto 1 hour after end of the operation (on arrival at the postanesthesia care unit)
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