Pediatric PateintsNCT02278003
A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients
A study testing memory test and Propofol in people with Pediatric Pateints and Amnesic Properties of Propofol, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to extend findings of propofol's effects on memory, as measured in volunteer research studies, to a clinical setting. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Pediatric Pateints, Amnesic Properties of Propofol
- What is being tested?
- memory test and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 10 May 2017
- Phase
- Interventional
- 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
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 propofol (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
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The goal of this study is to extend findings of propofol's effects on memory, as measured in volunteer research studies, to a clinical setting.
- Conditions
- Pediatric Pateints, Amnesic Properties of Propofol
- Being tested
- memory test, Propofol
- Keywords
- Amnesic, Propofol, 12-006
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
memory testOther
PropofolDrug
| Study group | Role | What they receive |
|---|---|---|
| children going under sedation with propofol | Experimental | Children who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion 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 propofol.
measure the amnesic effects of propofol. Receives: Other: memory test; Drug: Propofol |
| children not going under sedation | Active comparator | A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory. 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 infusion of propofol, 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: 1 year
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: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startFeb 2012
- Primary completion10 May 2017
- Study completion10 May 2017
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 Pediatric PateintsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Kelhoffer, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278003
- Sponsor's protocol ID
- 12-006
- Status last verified
- Jun 2017
- First submitted
- 24 Oct 2014
- Last updated
- 10 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Veselis R, Kelhoffer E, Mehta M, Root JC, Robinson F, Mason KP. Propofol sedation in children: sleep trumps amnesia. Sleep Med. 2016 Nov-Dec;27-28:115-120. doi: 10.1016/j.sleep.2016.10.002. Epub 2016 Oct 22.
PubMed 27938911
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients
- ClinicalTrials.gov ID
- NCT02278003
- Acronym / sponsor ID
- 12-006
- Conditions
- Pediatric Pateints, Amnesic Properties of Propofol
- Keywords
- Amnesic, Propofol, 12-006
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Posted 10 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to extend findings of propofol's effects on memory, as measured in volunteer research studies, to a clinical setting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| children going under sedation with propofol | Experimental | Other: memory test, Drug: PropofolChildren who will undergo sedation as part of their clinical management and give them a memory encoding task during propofol infusion 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 propofol. measure the amnesic effects of propofol. |
| children not going under sedation | Active comparator | Other: memory testA control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 propofol (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 |
|---|---|---|
| memory test | Other | children going under sedation with propofol, children not going under sedation |
| Propofol | Drug | children going under sedation with propofol |
Primary outcome
Sedation Threshold
Time frame: 1 year
During the 10-minute infusion of propofol, 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: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27938911Veselis R, Kelhoffer E, Mehta M, Root JC, Robinson F, Mason KP. Propofol sedation in children: sleep trumps amnesia. Sleep Med. 2016 Nov-Dec;27-28:115-120. doi: 10.1016/j.sleep.2016.10.002. Epub 2016 Oct 22.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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.
Eric Kelhoffer, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing memory test and Propofol in people with Pediatric Pateints and Amnesic Properties of Propofol, run by Memorial Sloan Kettering Cancer Center 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 10 Jan 2018. 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 10 Jan 2018). 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: 1 year). 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 NCT02278003, 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 10 Jan 2018.