MemoryNCT02354378

A Pilot Study to Assess the Amnesic Properties of Dexmedetomidine in Pediatric Patients

An observational study of Memory and Dexmedetomidine, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 4 to 14 years
Conditions the study is for: Memory, Dexmedetomidine
What is being tested?: Dexmedetomidine and Memory Test
How many people: 84 participants
Where: 1 siteUnited States
Study dates: Aug 2012to Mar 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 4 to 14 years
All sexes
No healthy volunteers
Child

Study population: Children between the ages of 4 and 14 years old either requiring sedation or attempting without sedation for MRI imaging will be offered inclusion in the study. Sedation will be administered per established and approved BCH sedation guidelines: over 10 minutes, a bolus of 2 mcg/kg of dexmedetomidine will be administered intravenously. The sedation process will not change for this study. During the bolus, pictures will be shown to the child who will be encouraged to name the item in the picture.

Who may be able to join

The patient must be between 4 and 14 yrs of age and be undergoing a therapeutic or diagnostic procedure with or without sedation
The patient must be able to comprehend and perform the task (naming pictures)
The patient must have a minimum weight of 8 kg

Who cannot join

Allergy to Dexmedetomidine (for those patients requiring sedation)
Procedure of short duration (< 15 min)
Pregnancy
Recent use (within 5 half-lives) of centrally acting medications that could affect concentration (e.g. diphenhydramine)

Trial locations and contacts

1 site in 1 country.

United States1 site

Boston Children's Hospital
Boston, Massachusetts, 02115

Other trials in United States

About this study

The goal of this study is to determine the effects of dexmedetomidine on memory and recall of children who are receiving dexmedetomidine sedation administered for magnetic resonance imaging (MRI) studies. Dexmedetomidine is currently the standard drug for sedation for diagnostic (MRI, computerized tomography (CT) and Nuclear Medicine) radiological studies at Boston Children's Hospital (BCH). The effect of dexmedetomidine on memory and recall in children has not been studied.

Conditions: Memory, Dexmedetomidine
Being tested: Dexmedetomidine, Memory Test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
Also called Precedex
Memory TestOther

Study groups in NCT02354378
Study group	Role	What they receive
Children undergoing sedation with Dexmedetomidine		Children who will undergo sedation for MRI will be given a memory encoding task during dexmedetomidine bolus induction to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of dexmedetomidine. Receives: Drug: Dexmedetomidine; Other: Memory Test
Children not undergoing sedation		A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing. Receives: Other: Memory Test

What is being measured

The primary outcome is the main question the study is designed to answer.

Sedation Threshold
During the 10-minute bolus infusion of Dexmedetomidine, children will be presented with pictures at 5-second intervals and asked to name the picture. They will be asked to name each picture (e.g., cat, tree, pencil, etc.). A valid response is naming of the picture within 5 seconds, either correctly or incorrectly.The important response measure is whether the child is awake enough to perform the naming task.
Measured: Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards

Secondary outcomes (1)

Memory Threshold
At the presentation of each picture, the child will be asked whether or not he/she remembers having seen it previously. Each response will be coded as correct (true positives and true negatives) or incorrect (false positives and false negatives)
Measured: Until 100 cards have been presented to the child. Approx. 10 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Mar 2015

First posted3 Feb 2015 (estimated)
Study startAug 2012
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MemoryStudies of the same condition, open and under way.
More trials run by Boston Children's HospitalThe 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02354378
Sponsor's protocol ID: IRB-P00004739
Status last verified: Oct 2018
First submitted: 29 Jan 2015
Last updated: 28 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mason KP, Kelhoffer ER, Prescilla R, Mehta M, Root JC, Young VJ, Robinson F, Veselis RA. Feasibility of measuring memory response to increasing dexmedetomidine sedation in children. Br J Anaesth. 2017 Feb;118(2):254-263. doi: 10.1093/bja/aew421.
PubMed 28100530

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study to Assess the Amnesic Properties of Dexmedetomidine in Pediatric Patients
ClinicalTrials.gov ID: NCT02354378
Acronym / sponsor ID: IRB-P00004739
Conditions: Memory, Dexmedetomidine
Study type: Observational
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Boston Children's HospitalUniversity, hospital or other
Collaborators: Memorial Sloan Kettering Cancer Center
Study start: Aug 2012
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 3 Feb 2015 (estimated)
Results: Posted 28 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Children undergoing sedation with Dexmedetomidine	–	Drug: Dexmedetomidine, Other: Memory TestChildren who will undergo sedation for MRI will be given a memory encoding task during dexmedetomidine bolus induction to measure the effects of sedation. The mere task of naming a picture will encode that picture into memory. When the anesthesia has worn off (at approximately 1 hour later), children will be given a memory recognition task to measure the amnesic effects of dexmedetomidine.
Children not undergoing sedation	–	Other: Memory TestA control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing.

Who may qualify

Ages: 4 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Children between the ages of 4 and 14 years old either requiring sedation or attempting without sedation for MRI imaging will be offered inclusion in the study. Sedation will be administered per established and approved BCH sedation guidelines: over 10 minutes, a bolus of 2 mcg/kg of dexmedetomidine will be administered intravenously. The sedation process will not change for this study. During the bolus, pictures will be shown to the child who will be encouraged to name the item in the picture.

Key inclusion criteria (3 listed)

The patient must be between 4 and 14 yrs of age and be undergoing a therapeutic or diagnostic procedure with or without sedation
The patient must be able to comprehend and perform the task (naming pictures)
The patient must have a minimum weight of 8 kg

Key exclusion criteria (4 listed)

Allergy to Dexmedetomidine (for those patients requiring sedation)
Procedure of short duration (< 15 min)
Pregnancy
Recent use (within 5 half-lives) of centrally acting medications that could affect concentration (e.g. diphenhydramine)

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
DexmedetomidineAlso: Precedex	Drug	Children undergoing sedation with Dexmedetomidine
Memory Test	Other	Children not undergoing sedation, Children undergoing sedation with Dexmedetomidine

Primary outcome

Sedation Threshold
Time frame: Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards
During the 10-minute bolus infusion of Dexmedetomidine, children will be presented with pictures at 5-second intervals and asked to name the picture. They will be asked to name each picture (e.g., cat, tree, pencil, etc.). A valid response is naming of the picture within 5 seconds, either correctly or incorrectly.The important response measure is whether the child is awake enough to perform the naming task.

1 secondary outcome

Memory Threshold
Time frame: Until 100 cards have been presented to the child. Approx. 10 minutes.

Results and safety

Results posted to the registry on 28 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Children Undergoing Sedation With Dexmedetomidine	64	30
Children Not Undergoing Sedation	20	16

Primary outcome: Sedation Threshold

Time frame: Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards. Mean (Standard Deviation). Unit: Number of Memory Cards

Measure	Children Undergoing Sedation With Dexmedetomidine n = 30	Children Not Undergoing Sedation n = 16
Value	26.8 (7.9)	38.9 (5.9)

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Children Undergoing Sedation With Dexmedetomidine	0 of 64 (0%)	0 of 64 (0%)	Not reported
Children Not Undergoing Sedation	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28100530Mason KP, Kelhoffer ER, Prescilla R, Mehta M, Root JC, Young VJ, Robinson F, Veselis RA. Feasibility of measuring memory response to increasing dexmedetomidine sedation in children. Br J Anaesth. 2017 Feb;118(2):254-263. doi: 10.1093/bja/aew421.

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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.

Keira Mason, MD principal investigator

Boston Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Memory and Dexmedetomidine, run by Boston Children's Hospital at 1 site in United States.

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 4 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 28 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 28 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Sedation Threshold (time frame: Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02354378, which also lists 1 linked publication.

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 28 Feb 2019.