Dexmedetomidine Intranasal for Single Ventricle Heart Disease (DexPK Trial)

Phase 1

Waitlist Available

Led By Jayant Pratap, MA,MB BChir,MRCPCH,FRCA

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after dex has been .

Awards & highlights

No Placebo-Only Group

Summary

This trial is continuing research on how well the drug dexmedetomidine is absorbed by the body when given as a nasal spray or orally, in order to determine the best dosage for children undergoing sedation or anesthesia using the drug.

Eligible Conditions

Single Ventricle Heart Disease
Heart Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after dex has been .

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after dex has been .

This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples will be drawn at 10, 20, 30, 40, 50, 60, 70, 80 and 90 minutes after dex has been . for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum blood concentration level of Dex - Cmax

The amount of time that Dex is present at the maximum concentration - Tmax

Secondary study objectives

Adverse events associated with Dex administration

Area under the curve for Dex concentration levels

Bioavailability of IN Dex relative to intravenous Dex for elimination - plasma concentration.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Intranasal DEX 4 mcg/kgExperimental Treatment1 Intervention

Standard anesthesia care for a patient presenting for cardiac surgery includes induction of general anesthesia, placement of an endotracheal tube and an arterial line. Once these are accomplished, Dexmedetomidine is administered according to group assignment.

Group II: Intranasal DEX 3 mcg/kgExperimental Treatment1 Intervention

Group III: Buccal DEX 2 mcg/kgExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexmedetomidine buccal

2018

Completed Phase 1

~20

Dexmedetomidine Intranasal

2018