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Pre-warmed Intravenous Fluids and Monitored Anesthesia Care

NCT ID: NCT01722955

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-11-30

Brief Summary

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The aim of the study is to compare effect of pre-warmed intravenous fluids on the early outcomes in ambulatory patients undergoing monitored anesthesia care.

Detailed Description

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Monitored anesthesia care (MAC) has been increasing in fast track anesthesia for ambulatory or outpatient surgery. MAC provides lower anesthetic agents than general anesthesia, however it has been shown to result high anesthetic complication rate because of negligent monitoring. Therefore, aim of this study is to investigate the effect of pre-warmed intravenous fluids on the core body temperature and the early outcomes.

Conditions

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Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Pre-warmed fluids

Pre-warmed fluids will be prepared for 8hous in 41℃ set hot cabinet.

Group Type EXPERIMENTAL

Pre-warmed fluids

Intervention Type OTHER

IV fluid will be stored at 41℃ set hot cabinet for 8hours

Room temperature fluids

Room temperature fluids will be stored at ambient temperature.

Group Type EXPERIMENTAL

Room temperature fluids

Intervention Type OTHER

Room temperature fluid will be stored at ambient temperature

Interventions

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Pre-warmed fluids

IV fluid will be stored at 41℃ set hot cabinet for 8hours

Intervention Type OTHER

Room temperature fluids

Room temperature fluid will be stored at ambient temperature

Intervention Type OTHER

Other Intervention Names

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Warming intravenous (IV) fluid No warming intravenous fluids

Eligibility Criteria

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Inclusion Criteria

* 20years to 70years old female patients undergoing urinary incontinence surgery under monitored anesthesia care.

Exclusion Criteria

* Preoperative tympanic membrane temperature \>38 or \< 36
* End stage heart failure or renal failure
* Otitis media
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Myung Hee Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Myung Hee Kim, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung MC

Locations

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Samsung medical center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Yokoyama K, Suzuki M, Shimada Y, Matsushima T, Bito H, Sakamoto A. Effect of administration of pre-warmed intravenous fluids on the frequency of hypothermia following spinal anesthesia for Cesarean delivery. J Clin Anesth. 2009 Jun;21(4):242-8. doi: 10.1016/j.jclinane.2008.12.010. Epub 2009 Jun 6.

Reference Type RESULT
PMID: 19502035 (View on PubMed)

Other Identifiers

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Prewarmed fluid

Identifier Type: -

Identifier Source: org_study_id