Trial Outcomes & Findings for A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients (NCT NCT02278003)
NCT ID: NCT02278003
Last Updated: 2018-01-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
69 participants
Primary outcome timeframe
1 year
Results posted on
2018-01-10
Participant Flow
Participant milestones
| Measure |
Children Going Under Sedation With Propofol
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.
memory test
Propofol
|
Children Not Going Under Sedation
A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.
memory test
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
20
|
|
Overall Study
COMPLETED
|
30
|
20
|
|
Overall Study
NOT COMPLETED
|
19
|
0
|
Reasons for withdrawal
| Measure |
Children Going Under Sedation With Propofol
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.
memory test
Propofol
|
Children Not Going Under Sedation
A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.
memory test
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
11
|
0
|
|
Overall Study
Not Treated
|
1
|
0
|
|
Overall Study
Recognition task improperly completed
|
7
|
0
|
Baseline Characteristics
A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Children Going Under Sedation With Propofol
n=30 Participants
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.
memory test
Propofol
|
Children Not Going Under Sedation
n=20 Participants
A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.
memory test
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.2 years
n=5 Participants
|
8.8 years
n=7 Participants
|
7.2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearDuring 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.
Outcome measures
| Measure |
Children Going Under Sedation With Propofol
n=30 Participants
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.
memory test
Propofol
|
Children Not Going Under Sedation
n=20 Participants
A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.
memory test
|
|---|---|---|
|
Sedation Threshold
Memory Lost w/in 2 minutes of sedation
|
29 Participants
|
NA Participants
This objective is only applicable to participants undergoing sedation.
|
|
Sedation Threshold
No memory loss w/in 2 minutes of sedation
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearAt 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).
Outcome measures
| Measure |
Children Going Under Sedation With Propofol
n=30 Participants
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.
memory test
Propofol
|
Children Not Going Under Sedation
n=20 Participants
A control group of children of similar age and undergoing similar minor therapeutic procedures will be recruited to perform memory.
memory test
|
|---|---|---|
|
Memory Threshold
|
0.71 Hit rate
Standard Deviation 0.16
|
0.93 Hit rate
Standard Deviation 0.06
|
Adverse Events
Children Going Under Sedation With Propofol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Children Not Going Under Sedation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Eric Kelhoffer, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-8781
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place