Trial Outcomes & Findings for A Pilot Study to Assess the Amnesic Properties of Propofol in Pediatric Patients (NCT 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

Target enrollment

69 participants

Primary outcome timeframe

1 year

Results posted on

2018-01-10

Participant Flow

Participant milestones

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

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

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=99 Participants	8.8 years n=107 Participants	7.2 years n=206 Participants
Sex: Female, Male Female	14 Participants n=99 Participants	11 Participants n=107 Participants	25 Participants n=206 Participants
Sex: Female, Male Male	16 Participants n=99 Participants	9 Participants n=107 Participants	25 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=99 Participants	18 Participants n=107 Participants	44 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) White	26 Participants n=99 Participants	18 Participants n=107 Participants	44 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Region of Enrollment United States	30 Participants n=99 Participants	20 Participants n=107 Participants	50 Participants n=206 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

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 year

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).

Outcome measures

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