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Completed

NCT Number: NCT01722955

Pre-warmed Intravenous Fluids and 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.

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Key information

Conditions

Hypothermia Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Samsung medical center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pre-warmed fluids

Other

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

Other names: Warming intravenous (IV) fluid

Room temperature fluids

Other

Room temperature fluid will be stored at ambient temperature

Other names: No warming intravenous fluids

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 7, 2012
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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