ChildrenNCT02931786
Effects of Propofol and Ketofol on Core Body Temperature in MRI
A study testing propofol and Ketamine propofol mixture in people with Children, run by Istanbul University.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Children
- What is being tested?
- propofol and Ketamine propofol mixture
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged between 6 months-10 years,
- underwent MRI under anesthesia
- ASA I-II
Who cannot join
- History of drug allergy
- Severe pulmonary and cardiac disease
- Intracranial hypertension
About this study
Official title: Does Magnetic Resonance Imaging Increase Core Body Temperature in Anesthetized Children? Evaluating the Effects of Propofol and Ketofol
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
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Also called propofol 1%
propofol, midazolam and atropine administration via intravenous cannula.
Ketamine propofol mixtureDrug
Also called ketofol
Administration of ketamine propofol mixture, midazolam and atropine via intravenous cannula
| Study group | Role | What they receive |
|---|---|---|
| propofol | Active comparator | body core temperature was measured from tympanic membrane after 1 mg/kg propofol administration, before and after magnetic resonance imaging Receives: Drug: propofol; Drug: 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 Receives: Drug: propofol; Drug: Ketamine propofol mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during magnetic resonance imaging (MRI) procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Cigdem Akyol Beyoğlu, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02931786
- Sponsor's protocol ID
- 118099
- Status last verified
- Nov 2017
- First submitted
- 19 Feb 2016
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Magnetic Resonance Imaging Increase Core Body Temperature in Anesthetized Children? Evaluating the Effects of Propofol and Ketofol
- ClinicalTrials.gov ID
- NCT02931786
- Acronym / sponsor ID
- 118099
- Conditions
- Children
- Keywords
- core body temperature, magnetic resonance imaging, propofol, ketofol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propofol | Active comparator | Drug: propofol, Drug: Ketamine propofol mixturebody core temperature was measured from tympanic membrane after 1 mg/kg propofol administration, before and after magnetic resonance imaging |
| ketofol | Active comparator | Drug: propofol, Drug: Ketamine propofol mixturebody 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 |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged between 6 months-10 years,
- underwent MRI under anesthesia
- ASA I-II
Key exclusion criteria (3 listed)
- History of drug allergy
- Severe pulmonary and cardiac disease
- Intracranial hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofolAlso: propofol 1%propofol, midazolam and atropine administration via intravenous cannula. | Drug | ketofol, propofol |
| Ketamine propofol mixtureAlso: ketofolAdministration of ketamine propofol mixture, midazolam and atropine via intravenous cannula | Drug | ketofol, propofol |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing propofol and Ketamine propofol mixture in people with Children, run by Istanbul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in core body temperature (time frame: during magnetic resonance imaging (MRI) procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2018.