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Pre-warmed Intravenous Fluids and Monitored Anesthesia Care

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01722955
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
26
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Pre-warmed fluids
  • Other: Room temperature fluids
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Pre-warmed Intravenous Fluids on the Early Outcomes After Ambulatory Surgery Under Monitored Anesthesia Care
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung medical center Seoul Korea, Republic of 135-710

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Myung Hee Kim, Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT01722955
    Other Study ID Numbers:
    • Prewarmed fluid
    First Posted:
    Nov 7, 2012
    Last Update Posted:
    Nov 19, 2014
    Last Verified:
    Nov 1, 2014
    Keywords provided by Myung Hee Kim, Professor, Samsung Medical Center
    Prewarmed fluid
    monitored anesthesia care
    core body temperature
    anesthetic satisfaction
    Additional relevant MeSH terms:
    Hypothermia

    Study Results

    No Results Posted as of Nov 19, 2014