Dexmedetomidine in Patients After Intracranial Surgery
NCT01445639 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 192
Last updated 2014-01-28
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
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