CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 33 enrolled
Drug / intervention
Dexmedetomidine +1 moredrug
Likely dose
Dexmedetomidine 1.0 mg/kg IV loading dose over 10 minutes, followed by 0.4–0.7 mg/kg/hour continuous infusionAI-extracted
Key inclusion· 3
  • Children age 6 months through 17 years undergoing interventional neuroradiologic procedures under general anesthesia
  • ASA physical status I–III
  • No anesthetic procedure for more than 30 days prior to enrollment
Key exclusion· 3
  • Current digoxin therapy
  • Severe congestive heart failure or pulmonary hypertension requiring vasodilators
  • Hepatic or renal dysfunction

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00857727
NCT00857727Phase 3Completed

Use of Dexmedetomidine for Emergence Delirium in Children Undergoing General Anesthesia for Endovascular Interventional Neuroradiologic Procedures

St. Luke's-Roosevelt Hospital Center·interventional·Posted Mar 9, 2009·Updated Nov 27, 2018

In Brief

A Phase 3 clinical trial evaluating Dexmedetomidine and Saline for Agitation and 2 related conditions. Completed, enrolled 33 participants across 1 site.

Detailed Summary

Emergence delirium (ED) from general anesthesia posts risk and harm to pediatric population undergo general anesthesia. The purpose of the study is to compare the use of dexmedetomidine versus placebo in reducing the incidence and severity of ED in a pediatric neurosurgical population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2009
Enrollment StartAug 1, 2009
Primary CompletionNov 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.3 years ago

Interventions

Dexmedetomidinedrug

Dexmedetomidine will be dissolved in saline. An initial loading dose of 1.0 mg/kg given over 10 minutes followed by a continuous infusion at 0.4-0.7 mg/kg/hour. Beginning approximately one hour prior to end of surgery and continuing for one hour of recovery in the PACU and the PICU. This, the maximum dose for any one patient will be 2.4 mg/kg

Salinedrug

Given by a continuous infusion