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Dexmedetomidine and Intelligence Development in Pediatric Patients Undergoing Craniotomy

NCT02810899 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-09-29

No results posted yet for this study

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.

Conditions

  • Brain Neoplasms

Interventions

DRUG

dexmedetomidine

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.

DRUG

normal saline

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

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    collaborator OTHER

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Dong-Xin Wang, MD, PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-02-29
Completion
2016-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02810899 on ClinicalTrials.gov