Dexmedetomidine in Patients After Intracranial Surgery

NCT01445639 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2014-01-28

No results posted yet for this study

Summary

Dexmedetomidine is a highly selective a2-adrenoreceptor agonist that produces dose-dependent sedation and analgesia without respiratory depression. Dexmedetomidine has been used in critically ill medical, surgical, and pediatric patients. No study has been designed specifically to evaluate dexmedetomidine uses in the neurocritical care population. The primary objective is to evaluate the safety and efficacy of dexmedetomidine for prophylactic analgesia and sedation in patients after intracranial surgery.

Conditions

Interventions

DRUG

Dexmedetomidine

Intravenous infusion at rate of 0.4μg/kg/h, during the first 24 hours postoperatively

DRUG

Normal saline

as placebo

Sponsors & Collaborators

  • Capital Medical University

    lead OTHER

Principal Investigators

  • Jian-Xin Zhou, MD · Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-12-31
Completion
2013-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT01445639 on ClinicalTrials.gov