10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature

Effect of 10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature in Patients Undergoing Urologic Surgery Under General Anesthesia

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

Study Overview

• Status: Completed
• Conditions: Urologic Diseases
• Intervention / Treatment: Other: prewarming and warmed fluid infusion

Detailed Description

During general anesthesia, vasodilation distributes body heat and leads to hypothermia. Especially during urologic operation (transurethral resection of bladder and prostate), bladder irrigation worsens hypothermia. Hence, various methods are used to maintain core temperature during operation.

Previous studies have demonstrated that prewarming of the patient is effective in maintaining core temperature perioperatively. However, more than 50% of patients who have applied prewarming for more than 30 minutes preoperatively are reported to fall in hypothermia. Hence, developing simple and effective method to prevent hypothermia is expected.

Hence, the investigators planned to examine the effect of active warming (10 minutes of prewarming preoperatively and prewarmed intravenous fluid intraoperatively) on hypothermia in patients undergoing urologic operation under general anesthesia.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

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: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergoing urologic surgery(transurethral resection of bladder, prostate)

Exclusion Criteria:

• moderate to severe cardiopulmonary, renal impairment
• 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 group patients are applied prewarming with bair-hugger (43'C)(warm touch, COVIDIEN, full body blanket) for 10 minutes in the preanesthetic unit prior to induction of anesthesia. During operation, prewarmed intravenous fluid which was stored in the warming cabinet for more than 8 hours is connected and infused. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation.	Other: prewarming and warmed fluid infusion; prewarming with forced air warming system and warmed fluid infusion.
No Intervention: no warming group; No warming group patients are not applied prewarming devices. Intravenous fluid stored in room air is connected and infused during the operation. Forced air blanket (warm touch, COVIDIEN, upper body blanket) with 38'C is applied for all patients during the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of hypothermia at the end of the operation	after completion 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 before and end of operation	change in core temperature will be calculated and compared	on arrival at the OR upto 1-2hours after induction (at the end of the operation)
incidence of shivering	shivering will be evaluated using 4 point shivering scale (0=none, 1=core and neck shivering, 2= upper extremity 3= whole body)	upto 1 hour after end of the operation (on arrival at the postanesthesia care unit)
thermal comfort	thermal comfort will be evaluated using thermal comfort scale ( 0= very cold, 5= fine, 10= very hot and uncomfortable)	upto 1hour after end of the operation (at discharge of postanesthesia care unit)

Collaborators and Investigators

• Sponsor: Inje University
• Investigators: Principal Investigator: In-Jung Jun, MD. PhD, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): August 25, 2022
• Study Completion (Actual): August 25, 2022

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: hypothermia
• Additional Relevant MeSH Terms: Urologic Diseases
• Other Study ID Numbers: 2021-05-004

Drug and device information, study documents

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