Pre-warmed Intravenous Fluids and Monitored Anesthesia Care

Not Applicable

Completed

• Conditions: Hypothermia
• Interventions: Other: Pre-warmed fluids; Other: Room temperature fluids

• Registration Number: NCT01722955
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-11-04
• Study First Submitted QC: 2012-11-04
• Study First Posted: 2012-11-07
• Status Verified: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Last Update Submitted: 2014-11-17
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

• Preoperative tympanic membrane temperature >38 or < 36
• End stage heart failure or renal failure
• Otitis media

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-warmed fluids	Pre-warmed fluids	Pre-warmed fluids will be prepared for 8hous in 41℃ set hot cabinet.
Room temperature fluids	Room temperature fluids	Room temperature fluids will be stored at ambient temperature.

Primary Outcome Measures

Name	Time	Method
Tympanic membrane temperature	30min after anesthetic induction	Preoperative dehydration will be supplemented with 10ml/kg of lactate Ringer's solution at the beginning of the anesthetic induction. 30 min after anesthetic induction is nearly after administering the fixed volume.

Secondary Outcome Measures

Name	Time	Method
Postoperative chilling and shivering	on arrival at the postanesthetic care unit ( 1hour after the anesthetic induction)	Degree of chilling and shivering will be evaluated at the postanesthesia care unit after the surgery.

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of