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Effect of Prewarming During Induction of General Anesthesia Combined With Warmed Intravenous Fluid on Core Temperature.

Primary Purpose

Urologic Diseases

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
warming during induction of anesthesia
Prewarmed intravenous fluid administration
Sponsored by
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urologic Diseases

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sanggye paik hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

warming group

no warming group

Arm Description

warming of the patient with whole body warming blanket in the OR during induction of anesthesia, prewarmed intravenous fluid during the operation.

There will be no whole body warming during induction.

Outcomes

Primary Outcome Measures

incidence of hypothermia at the end of the operation
number of patients with hypothermia (<36'C) using esophageal stethoscope will be recorded.

Secondary Outcome Measures

change in temperature drop before and end of operation
change in core temperature will be observed
thermal comfort
thermal comfort scale ( 0= very cold, 5= fine, 10= very hot and uncomfortable) will be used.
incidence of shivering
4 point shivering scale (0=none, 1=core and neck shivering, 2= upper extremity 3= whole body) will be used.

Full Information

First Posted
November 23, 2022
Last Updated
August 29, 2023
Sponsor
Inje University
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1. Study Identification

Unique Protocol Identification Number
NCT05636189
Brief Title
Effect of Prewarming During Induction of General Anesthesia Combined With Warmed Intravenous Fluid on Core Temperature.
Official Title
Effect of Prewarming During Induction of General Anesthesia Combined With Warmed Intravenous Fluid on Core Temperature in Patients Undergoing Urologic Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
August 8, 2023 (Actual)
Study Completion Date
August 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
warming group
Arm Type
Active Comparator
Arm Description
warming of the patient with whole body warming blanket in the OR during induction of anesthesia, prewarmed intravenous fluid during the operation.
Arm Title
no warming group
Arm Type
No Intervention
Arm Description
There will be no whole body warming during induction.
Intervention Type
Procedure
Intervention Name(s)
warming during induction of anesthesia
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Prewarmed intravenous fluid administration
Intervention Description
Prewarmed intravenous fluid is connected.
Primary Outcome Measure Information:
Title
incidence of hypothermia at the end of the operation
Description
number of patients with hypothermia (<36'C) using esophageal stethoscope will be recorded.
Time Frame
approximately 1-2hours after induction (at the end of operation)
Secondary Outcome Measure Information:
Title
change in temperature drop before and end of operation
Description
change in core temperature will be observed
Time Frame
on arrival at the OR upto 1-2hours after induction (at the end of the operation)
Title
thermal comfort
Description
thermal comfort scale ( 0= very cold, 5= fine, 10= very hot and uncomfortable) will be used.
Time Frame
upto 1hour after end of the operation (at discharge of postanesthesia care unit)
Title
incidence of shivering
Description
4 point shivering scale (0=none, 1=core and neck shivering, 2= upper extremity 3= whole body) will be used.
Time Frame
upto 1 hour after end of the operation (on arrival at the postanesthesia care unit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Jung Jun, MD, PhD
Organizational Affiliation
assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanggye paik hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Prewarming During Induction of General Anesthesia Combined With Warmed Intravenous Fluid on Core Temperature.

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