Pre-warmed Intravenous Fluids and Monitored Anesthesia Care

November 17, 2014 updated by: Myung Hee Kim, Samsung Medical Center

Effect of Pre-warmed Intravenous Fluids on the Early Outcomes After Ambulatory Surgery Under Monitored Anesthesia Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pre-warmed fluids
Pre-warmed fluids will be prepared for 8hous in 41℃ set hot cabinet.
Other: Pre-warmed fluids
IV fluid will be stored at 41℃ set hot cabinet for 8hours
Other Names:
  • Warming intravenous (IV) fluid
Experimental: Room temperature fluids
Room temperature fluids will be stored at ambient temperature.
Other: Room temperature fluids
Room temperature fluid will be stored at ambient temperature
Other Names:
  • No warming intravenous fluids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tympanic membrane temperature
Time Frame: 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.
30min after anesthetic induction

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative chilling and shivering
Time Frame: 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.
on arrival at the postanesthetic care unit ( 1hour after the anesthetic induction)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Myung Hee Kim, MD,PhD, Samsung MC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 4, 2012

First Submitted That Met QC Criteria

November 4, 2012

First Posted (Estimate)

November 7, 2012

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Prewarmed fluid

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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