Back to resultsPre-warmed Intravenous Fluids and Monitored Anesthesia Care
Primary Purpose
Hypothermia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pre-warmed fluids
Room temperature fluids
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia focused on measuring Prewarmed fluid, monitored anesthesia care, core body temperature, anesthetic satisfaction
Eligibility Criteria
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
Sites / Locations
- Samsung medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pre-warmed fluids
Room temperature fluids
Arm Description
Pre-warmed fluids will be prepared for 8hous in 41℃ set hot cabinet.
Room temperature fluids will be stored at ambient temperature.
Outcomes
Primary Outcome Measures
Tympanic membrane temperature
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
Postoperative chilling and shivering
Degree of chilling and shivering will be evaluated at the postanesthesia care unit after the surgery.
Full Information
NCT ID
NCT01722955
First Posted
November 4, 2012
Last Updated
November 17, 2014
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01722955
Brief Title
Pre-warmed Intravenous Fluids and Monitored Anesthesia Care
Official Title
Effect of Pre-warmed Intravenous Fluids on the Early Outcomes After Ambulatory Surgery Under Monitored Anesthesia Care
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
Prewarmed fluid, monitored anesthesia care, core body temperature, anesthetic satisfaction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-warmed fluids
Arm Type
Experimental
Arm Description
Pre-warmed fluids will be prepared for 8hous in 41℃ set hot cabinet.
Arm Title
Room temperature fluids
Arm Type
Experimental
Arm Description
Room temperature fluids will be stored at ambient temperature.
Intervention Type
Other
Intervention Name(s)
Pre-warmed fluids
Other Intervention Name(s)
Warming intravenous (IV) fluid
Intervention Description
IV fluid will be stored at 41℃ set hot cabinet for 8hours
Intervention Type
Other
Intervention Name(s)
Room temperature fluids
Other Intervention Name(s)
No warming intravenous fluids
Intervention Description
Room temperature fluid will be stored at ambient temperature
Primary Outcome Measure Information:
Title
Tympanic membrane temperature
Description
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.
Time Frame
30min after anesthetic induction
Secondary Outcome Measure Information:
Title
Postoperative chilling and shivering
Description
Degree of chilling and shivering will be evaluated at the postanesthesia care unit after the surgery.
Time Frame
on arrival at the postanesthetic care unit ( 1hour after the anesthetic induction)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myung Hee Kim, MD,PhD
Organizational Affiliation
Samsung MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung medical center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
19502035
Citation
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.
Results Reference
result
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Pre-warmed Intravenous Fluids and Monitored Anesthesia Care
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