10 Minutes Prewarming and Warmed Intravenous Fluid on Core Temperature

NCT ID: NCT04991272

Last Updated: 2022-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-08-25

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.

Conditions

Urologic Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

prewarming and warmed fluid infusion

Intervention Type: OTHER

prewarming with forced air warming system and warmed fluid infusion.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

prewarming and warmed fluid infusion

prewarming with forced air warming system and warmed fluid infusion.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inje University

OTHER

Sponsor Role: lead

Responsible Party

In-Jung Jun

MD. PhD. associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

In-Jung Jun, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Associate professor

Locations

Sanggye Paik Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2021-05-004

Identifier Type: -

Identifier Source: org_study_id