Effects of Propofol and Ketofol on Core Body Temperature in MRI

Not Applicable

Completed

• Conditions: Children
• Interventions: Drug: propofol; Drug: Ketamine propofol mixture

• Registration Number: NCT02931786
• Lead Sponsor: Istanbul University

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

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 Timeline

• Study Start: 2014-08
• Primary Completion: 2015-02
• Study Completion: 2016-02
• Study First Submitted: 2016-02-19
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-13
• Status Verified: 2017-11
• Last Update Submitted: 2018-02-16
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
propofol	propofol	body core temperature was measured from tympanic membrane after 1 mg/kg propofol administration, before and after magnetic resonance imaging
propofol	Ketamine propofol mixture	body core temperature was measured from tympanic membrane after 1 mg/kg propofol administration, before and after magnetic resonance imaging
ketofol	Ketamine propofol mixture	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
ketofol	propofol	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

Primary Outcome Measures

Name	Time	Method
Change in core body temperature	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.