Effect of Prewarming During Induction of General Anesthesia Combined With Warmed Intravenous Fluid on Core Temperature.
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2022
CompletedFirst Submitted
Initial submission to the registry
November 23, 2022
CompletedFirst Posted
Study publicly available on registry
December 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2023
CompletedAugust 30, 2023
August 1, 2023
9 months
November 23, 2022
August 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
change in temperature drop before and end of operation
on arrival at the OR upto 1-2hours after induction (at the end of the operation)
thermal comfort
upto 1hour after end of the operation (at discharge of postanesthesia care unit)
incidence of shivering
upto 1 hour after end of the operation (on arrival at the postanesthesia care unit)
Study Arms (2)
warming group
ACTIVE COMPARATORwarming of the patient with whole body warming blanket in the OR during induction of anesthesia, prewarmed intravenous fluid during the operation.
no warming group
NO INTERVENTIONThere will be no whole body warming during induction.
Interventions
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 is connected.
Eligibility Criteria
You may qualify if:
- patients undergoing urologic surgery(transurethral resection of bladder, prostate)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inje Universitylead
Study Sites (1)
Sanggye paik hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
In-Jung Jun, MD, PhD
assistant professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
November 23, 2022
First Posted
December 5, 2022
Study Start
November 1, 2022
Primary Completion
August 8, 2023
Study Completion
August 8, 2023
Last Updated
August 30, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share