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

Sponsor

Inje University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05636189

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urologic Diseases	Procedure: warming during induction of anesthesia Procedure: Prewarmed intravenous fluid administration	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Prewarming During Induction of General Anesthesia Combined With Warmed Intravenous Fluid on Core Temperature in Patients Undergoing Urologic Surgery.

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: warming group warming of the patient with whole body warming blanket in the OR during induction of anesthesia, prewarmed intravenous fluid during the operation.	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. Procedure: Prewarmed intravenous fluid administration Prewarmed intravenous fluid is connected.
No Intervention: no warming group There will be no whole body warming during induction.

Arm

Intervention/Treatment

Active Comparator: warming group

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

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.

Procedure: Prewarmed intravenous fluid administration

Prewarmed intravenous fluid is connected.

No Intervention: no warming group

There will be no whole body warming during induction.

Outcome Measures

Primary Outcome Measures

incidence of hypothermia at the end of the operation [approximately 1-2hours after induction (at the end of 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 [on arrival at the OR upto 1-2hours after induction (at the end of the operation)]
change in core temperature will be observed
thermal comfort [upto 1hour after end of the operation (at discharge of postanesthesia care unit)]
thermal comfort scale ( 0= very cold, 5= fine, 10= very hot and uncomfortable) will be used.
incidence of shivering [upto 1 hour after end of the operation (on arrival at the postanesthesia care unit)]
4 point shivering scale (0=none, 1=core and neck shivering, 2= upper extremity 3= whole body) will be used.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanggye paik hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Inje University

Investigators

Principal Investigator: In-Jung Jun, MD, PhD, assistant professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

In-Jung Jun, assistant professor, Inje University

ClinicalTrials.gov Identifier:

NCT05636189

Other Study ID Numbers:

2022-08-011-001

First Posted:

Dec 5, 2022

Last Update Posted:

Dec 7, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urologic Diseases

Anesthetics

Study Results

No Results Posted as of Dec 7, 2022