NCT01722955

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

2.2 years

First QC Date

November 4, 2012

Last Update Submit

November 17, 2014

Conditions

Keywords

Prewarmed fluidmonitored anesthesia carecore body temperatureanesthetic satisfaction

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

EXPERIMENTAL

Pre-warmed fluids will be prepared for 8hous in 41℃ set hot cabinet.

Other: Pre-warmed fluids

Room temperature fluids

EXPERIMENTAL

Room temperature fluids will be stored at ambient temperature.

Other: Room temperature fluids

Interventions

IV fluid will be stored at 41℃ set hot cabinet for 8hours

Also known as: Warming intravenous (IV) fluid
Pre-warmed fluids

Room temperature fluid will be stored at ambient temperature

Also known as: No warming intravenous fluids
Room temperature fluids

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Hypothermia

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Myung Hee Kim, MD,PhD

    Samsung MC

    PRINCIPAL INVESTIGATOR

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

Locations