Pre-warmed Intravenous Fluids and Monitored Anesthesia Care
Effect of Pre-warmed Intravenous Fluids on the Early Outcomes After Ambulatory Surgery Under Monitored Anesthesia Care
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 4, 2012
CompletedFirst Posted
Study publicly available on registry
November 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedNovember 19, 2014
November 1, 2014
2.2 years
November 4, 2012
November 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30min after anesthetic induction
Secondary Outcomes (1)
Postoperative chilling and shivering
on arrival at the postanesthetic care unit ( 1hour after the anesthetic induction)
Study Arms (2)
Pre-warmed fluids
EXPERIMENTALPre-warmed fluids will be prepared for 8hous in 41℃ set hot cabinet.
Room temperature fluids
EXPERIMENTALRoom temperature fluids will be stored at ambient temperature.
Interventions
IV fluid will be stored at 41℃ set hot cabinet for 8hours
Room temperature fluid will be stored at ambient temperature
Eligibility Criteria
You may qualify if:
- years to 70years old female patients undergoing urinary incontinence surgery under monitored anesthesia care.
You may not qualify if:
- Preoperative tympanic membrane temperature \>38 or \< 36
- End stage heart failure or renal failure
- Otitis media
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung medical center
Seoul, 135-710, South Korea
Related Publications (1)
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.
PMID: 19502035RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myung Hee Kim, MD,PhD
Samsung MC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 4, 2012
First Posted
November 7, 2012
Study Start
September 1, 2012
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
November 19, 2014
Record last verified: 2014-11