10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature

Urologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04991272
• Other study ID #: 2021-05-004
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: August 25, 2022

Study information

• Verified date: November 2022
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 25, 2022
• Est. primary completion date: August 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Urologic Diseases

Intervention

Other:
• prewarming and warmed fluid infusion
prewarming with forced air warming system and warmed fluid infusion.

Locations

Country	Name	City	State
Korea, Republic of	Sanggye Paik Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)