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

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.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine; Memory
• Intervention / Treatment: Drug: Dexmedetomidine; Other: Memory Test

• Study Type: Observational
• Enrollment (Actual): 84

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Dexmedetomidine; Other Names: Precedex; 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.	Other: Memory Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Until the child has reviewed cards and is under sedation or for the control group has reviewed 100 cards

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Until 100 cards have been presented to the child. Approx. 10 minutes.

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Keira Mason, MD, Boston Children's Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 29, 2015
• First Submitted That Met QC Criteria: January 29, 2015
• First Posted (Estimate): February 3, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: IRB-P00004739