Pre-warmed Intravenous Fluids and Monitored Anesthesia Care

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722955
• Other study ID #: Prewarmed fluid
• Status: Completed
• Phase: N/A
• First received: November 4, 2012
• Last updated: November 17, 2014
• Start date: September 2012
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia

Intervention

Other:
• Pre-warmed fluids
IV fluid will be stored at 41? set hot cabinet for 8hours
• Room temperature fluids
Room temperature fluid will be stored at ambient temperature

Locations

Country	Name	City	State
Korea, Republic of	Samsung medical center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & 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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Postoperative chilling and shivering	Degree of chilling and shivering will be evaluated at the postanesthesia care unit after the surgery.	on arrival at the postanesthetic care unit ( 1hour after the anesthetic induction)	Yes