10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature

Not Applicable

Completed

• Conditions: Urologic Diseases
• Interventions: Other: prewarming and warmed fluid infusion

• Registration Number: NCT04991272
• Lead Sponsor: Inje University

Brief Summary

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

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 Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-08-02
• Study First Posted: 2021-08-05
• Primary Completion: 2022-08-25
• Study Completion: 2022-08-25
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-23
• Last Update Posted: 2022-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
warming group	prewarming and warmed fluid infusion	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.

Primary Outcome Measures

Name	Time	Method
incidence of hypothermia at the end of the operation	approximately 1-2hours after induction (at the end of operation)	after completion of the operation, number of patients with hypothermia (\<36'C) using esophageal stethoscope will be recorded.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sanggye Paik Hospital; 🇰🇷 Seoul, Korea, Republic of