Effects of Propofol and Ketofol on Core Body Temperature in MRI

Children Clinical Trial

Official title:

Does Magnetic Resonance Imaging Increase Core Body Temperature in Anesthetized Children? Evaluating the Effects of Propofol and Ketofol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02931786
• Other study ID #: 118099
• Status: Completed
• Phase: N/A
• First received: February 19, 2016
• Last updated: February 16, 2018
• Start date: August 2014
• Est. completion date: February 2016

Study information

• Verified date: November 2017
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators researched the effect of two different types of drugs on core body temperature during magnetic resonance imaging. The hypothesis is in ketamine group, thermo disregulation is not as distinct as in propofol group, due to its positive effect on thermo regulation

Description:

Intravenous anesthetics may impair thermoregulation. Absorption of radiofrequency waves by the body surface may result in heating, especially in small children during magnetic resonance imaging (MRI). Investigators applied two different intravenous anesthetics as propofol and ketamine and studied the effect of these drugs on core body temperature.

All patients aged between 6 months-10 years were administered midazolam and atropine. After that 1 mg/ kg of propofol was applied in group I, and 0,1 ml/kg of propofol ketamine mixture ( 10 mg/ml each) was applied in group II. Core body temperatures were taken before and after MRI and compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 10 Years

Eligibility

Inclusion Criteria:

• children aged between 6 months-10 years,

• underwent MRI under anesthesia

• ASA I-II

Exclusion Criteria:

• History of drug allergy

• Severe pulmonary and cardiac disease

• Intracranial hypertension

Related Conditions & MeSH terms

• Children

Intervention

Drug:
• propofol
propofol, midazolam and atropine administration via intravenous cannula.
• Ketamine propofol mixture
Administration of ketamine propofol mixture, midazolam and atropine via intravenous cannula

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in core body temperature	temperature was taken from tympanic membrane bilaterally before and after MRI. If temperature change was more or les than 0.1 degrees celsius the patient was considered as warmer or cooler.	during magnetic resonance imaging (MRI) procedure