Effects of Propofol and Ketofol on Core Body Temperature in MRI

Ketamine

Brief 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

Intervention / Treatment

  • Propofol (DRUG)
    propofol, midazolam and atropine administration via intravenous cannula.
  • Ketamine propofol mixture (DRUG)
    Administration of ketamine propofol mixture, midazolam and atropine via intravenous cannula

Condition or Disease

  • Children

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 6 Months to 10 Years
    Enrollment: 90 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 01, 2014
    Primary Completion: Feb 01, 2015 ACTUAL
    Completion Date: Feb 01, 2016 ACTUAL
    Study First Posted: Oct 13, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Feb 16, 2018

    Sponsors / Collaborators

    Lead Sponsor: Istanbul University
    Responsible Party: N/A

    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.

    Participant Groups

    • body core temperature was measured from tympanic membrane after 1 mg/kg propofol administration, before and after magnetic resonance imaging

    • 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

    Eligibility Criteria

    Sex: All
    Minimum Age: 1
    Maximum Age: 10
    Age Groups: Child
    Healthy Volunteers: Yes

    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

    Primary Outcomes

    • 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.

    More Details

    NCT Number: NCT02931786
    Other IDs: 118099
    Study URL: https://clinicaltrials.gov/study/NCT02931786
    Last updated: Sep 29, 2023