Effects of Propofol and Ketofol on Core Body Temperature in MRI

February 16, 2018 updated by: Dr Cigdem Akyol Beyoğlu, Istanbul University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 10 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: propofol
body core temperature was measured from tympanic membrane after 1 mg/kg propofol administration, before and after magnetic resonance imaging
Drug: propofol
propofol, midazolam and atropine administration via intravenous cannula.
Other Names:
  • propofol 1%
Drug: Ketamine propofol mixture
Administration of ketamine propofol mixture, midazolam and atropine via intravenous cannula
Other Names:
  • ketofol
Active Comparator: ketofol
body core temperature was measured from tympanic membrane after 0,1 ml/kg administration of ketamine propofol mixture of 10 mg/ml both, before and after magnetic resonance imaging
Drug: propofol
propofol, midazolam and atropine administration via intravenous cannula.
Other Names:
  • propofol 1%
Drug: Ketamine propofol mixture
Administration of ketamine propofol mixture, midazolam and atropine via intravenous cannula
Other Names:
  • ketofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in core body temperature
Time Frame: during magnetic resonance imaging (MRI) procedure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

February 19, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 13, 2016

Study Record Updates

Last Update Posted (Actual)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 16, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 118099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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