NCT02931786

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2016

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
Last Updated

February 19, 2018

Status Verified

November 1, 2017

Enrollment Period

6 months

First QC Date

February 19, 2016

Last Update Submit

February 16, 2018

Conditions

Children

Keywords

core body temperaturemagnetic resonance imagingpropofolketofol

Outcome Measures

Primary Outcomes (1)

  • Change in core body temperature

    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

Study Arms (2)

propofol

ACTIVE COMPARATOR

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

Drug: propofolDrug: Ketamine propofol mixture

ketofol

ACTIVE COMPARATOR

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: propofolDrug: Ketamine propofol mixture

Interventions

propofolDRUG

propofol, midazolam and atropine administration via intravenous cannula.

Also known as: propofol 1%
ketofolpropofol
Ketamine propofol mixtureDRUG

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

Also known as: ketofol
ketofolpropofol

Eligibility Criteria

Age6 Months - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children aged between 6 months-10 years,
  • underwent MRI under anesthesia
  • ASA I-II

You may not qualify if:

  • History of drug allergy
  • Severe pulmonary and cardiac disease
  • Intracranial hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical specialist

Study Record Dates

First Submitted

February 19, 2016

First Posted

October 13, 2016

Study Start

August 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2016

Last Updated

February 19, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share