CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
dexmedetomidine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02810899
NCT02810899Phase 4Completed
CompareCT.gov

The Effect of Dexmedetomidine as an Adjuvant to General Anesthesia on Intelligence Development in Pediatric Patients Undergoing Craniotomy: a Randomized, Double-blind and Placebo-controlled Pilot Trial

Peking University First Hospital·interventional·Posted Jun 23, 2016·Updated Sep 29, 2016

In Brief

A Phase 4 clinical trial evaluating dexmedetomidine and normal saline for Brain Neoplasms. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The purpose of this randomized, double-blind and placebo-controlled pilot study is to investigate whether dexmedetomidine when used as an adjuvant to general anesthesia can decrease the harmful effects of anesthesia and surgery on intelligence development in pediatric patients undergoing craniotomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Neoplasms
CountriesChina
CollaboratorsBeijing Tiantan Hospital

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 23, 2016
Enrollment StartSep 1, 2015
Primary CompletionFeb 1, 2016
Study CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.0 years ago

Interventions

dexmedetomidinedrug

A loading dose dexmedetomidine (0.5 ug/kg IV infused in 15 minutes) will be administered after anesthesia induction, followed by a continuous infusion at a rate of 0.5 ug/kg/h until the closure of the brain duramater at the end of surgery.

normal salinedrug

Normal saline will be administered in the same rate, volume and duration as that in the dexmedetomidine group