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Dexmedetomidine in Patients After Intracranial Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01445639
Recruitment Status : Completed
First Posted : October 4, 2011
Last Update Posted : January 28, 2014
Information provided by (Responsible Party):
Jian-Xin Zhou, Capital Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Central Nervous System Diseases Drug: Dexmedetomidine Drug: Normal saline Phase 4

Detailed Description:
The PASTrial is a non-commercial, multi-center, randomized, placebo-controlled, double blinded clinical trial. The study compares dexmedetomidine versus normal saline (placebo) in patients after intracranial surgery with delayed extubation. In dexmedetomidine group, infusion (0.4μg/kg/h) is started when patients are admitted to neuro-intensive care unit for postoperative recovery. In control group, patients receive normal saline infusion at the same rate and volume in dexmedetomidine group. The patient's level of sedation is assessed by Sedation-Agitation Scale (SAS) per hour. Midazolam is administered in 0.3-0.5 mg bolus or continuous infusion as SAS above 4. The study is designed primarily to compare the percentage of patients with agitation and requiring midazolam infusion in the 2 study arms.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Dexmedetomidine for Prophylactic Analgesia and Sedation in Patients After Intracranial Surgery (Prophylactic Analgesia and Sedation Trial, PASTrial)
Study Start Date : October 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Dexmedetomidine group Drug: Dexmedetomidine
Intravenous infusion at rate of 0.4μg/kg/h, during the first 24 hours postoperatively

Placebo Comparator: Placebo group Drug: Normal saline
as placebo

Primary Outcome Measures :
  1. Mean percentage of hours of optimal sedation. [ Time Frame: 24 hours postoperative ]
    Optimal sedation is defined as SAS score 4.

Secondary Outcome Measures :
  1. Percentage of patients with agitation and receiving additional sedatives. [ Time Frame: During the first 24 hours postoperatively ]
    Agitation is defined as SAS above 4. Patients are given midazolam as agitation.

Other Outcome Measures:
  1. Percentage of patients with adverse events. [ Time Frame: During the first 24 hours postoperatively ]
    Adverse events include hypotension, bradycardia, airway obstruction, apnea, and consciousness disorders

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients after intracranial surgery with delayed extubation

Exclusion Criteria:

  • emergency operation
  • brain stem operation
  • preoperative consciousness disorders or epilepsy
  • bradycardia, hypotension, acute myocardial infarction, second- or third degree heart block, or need continuous infusions of vasopressor before the start of study drug infusion
  • patients enrolled in another trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01445639

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China, Beijing
Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Capital Medical University
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Study Chair: Jian-Xin Zhou, MD Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University

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Responsible Party: Jian-Xin Zhou, Professor, Capital Medical University Identifier: NCT01445639    
Other Study ID Numbers: BTH-NICU-2011-02
2009-03-28 ( Other Grant/Funding Number: Beijing Municipal Health Bureau, Beijing, China )
First Posted: October 4, 2011    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: January 2014
Keywords provided by Jian-Xin Zhou, Capital Medical University:
postoperative care
Additional relevant MeSH terms:
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Central Nervous System Diseases
Nervous System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action