Trial Outcomes & Findings for A Pilot Study to Assess the Amnesic Properties of Dexmedetomidine in Pediatric Patients (NCT NCT02354378)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

84 participants

Primary outcome timeframe

Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards

Results posted on

2019-02-28

Participant Flow

Participant milestones

Participant milestones
Measure	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. Dexmedetomidine 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. Memory Test
Overall Study STARTED	64	20
Overall Study COMPLETED	30	16
Overall Study NOT COMPLETED	34	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Children Undergoing Sedation With Dexmedetomidine n=30 Participants 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. Dexmedetomidine Memory Test	Children Not Undergoing Sedation n=16 Participants A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing. Memory Test	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	30 Participants n=5 Participants	16 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	6.1 years STANDARD_DEVIATION 1.2 • n=5 Participants	9.5 years STANDARD_DEVIATION 1.9 • n=7 Participants	7.7 years STANDARD_DEVIATION 2.2 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	8 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	16 Participants n=7 Participants	46 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Children Undergoing Sedation With Dexmedetomidine n=30 Participants 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. Dexmedetomidine Memory Test	Children Not Undergoing Sedation n=16 Participants A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing. Memory Test
Sedation Threshold	26.8 Number of Memory Cards Standard Deviation 7.9	38.9 Number of Memory Cards Standard Deviation 5.9

SECONDARY outcome

Timeframe: Until 100 cards have been presented to the child. Approx. 10 minutes.

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 Undergoing Sedation With Dexmedetomidine n=30 Participants 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. Dexmedetomidine Memory Test	Children Not Undergoing Sedation n=16 Participants A control group of children of similar age scheduled for MRI will be recruited to perform memory recognition testing. Memory Test
Memory Threshold	35.1 Number of Memory Cards seen before scan Standard Deviation 6.6	50 Number of Memory Cards seen before scan Standard Deviation 0

Adverse Events

Children Undergoing Sedation With Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Children Not Undergoing 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

Keira Mason, MD

Boston Children's Hospital

Phone: 6173552339

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place