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

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

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.

Study Overview

• Status: Completed
• Conditions: Urologic Diseases
• Intervention / Treatment: Procedure: warming during induction of anesthesia; Procedure: Prewarmed intravenous fluid administration

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: In-Jung Jun, MD, PhD; Phone Number: 82-10-9312-0162; Email: s5643@paik.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Sanggye Paik hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Inje University
• Investigators: Principal Investigator: In-Jung Jun, MD, PhD, Assistant Professor

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): August 8, 2023
• Study Completion (Actual): August 8, 2023

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2022-08-011-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No