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OpenTrials
Completed

NCT Number: NCT02931786

Effects of Propofol and Ketofol on Core Body Temperature in MRI

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

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Key information

Conditions

Age range

6 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Propofol

Drug

propofol, midazolam and atropine administration via intravenous cannula.

Other names: propofol 1%

Ketamine propofol mixture

Drug

Administration of ketamine propofol mixture, midazolam and atropine via intravenous cannula

Other names: ketofol

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Oct 13, 2016
Registry last updated
Feb 19, 2018

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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