Effects of Propofol and Ketofol on Core Body Temperature in MRI

NCT ID: NCT02931786

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-02-29

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.

Conditions

Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

propofol

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

Group Type: ACTIVE_COMPARATOR

propofol

Intervention Type: DRUG

propofol, midazolam and atropine administration via intravenous cannula.

Ketamine propofol mixture

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

propofol

Intervention Type: DRUG

propofol, midazolam and atropine administration via intravenous cannula.

Ketamine propofol mixture

Intervention Type: DRUG

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

Interventions

propofol

propofol, midazolam and atropine administration via intravenous cannula.

Intervention Type: DRUG

Ketamine propofol mixture

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

Intervention Type: DRUG

Other Intervention Names

propofol 1%; ketofol

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Dr Cigdem Akyol Beyoğlu

medical specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

118099

Identifier Type: -

Identifier Source: org_study_id