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Dexmedetomidine in Patients After Intracranial Surgery

This study is currently recruiting participants.
Verified October 2012 by Capital Medical University
Sponsor:
Information provided by (Responsible Party):
Jian-Xin Zhou, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01445639
First received: September 30, 2011
Last updated: October 22, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Central Nervous System Diseases
 Drug: Dexmedetomidine
Drug: Normal saline
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • Mean percentage of hours of optimal sedation. [ Time Frame: 24 hours postoperative ] [ Designated as safety issue: No ]
    Optimal sedation is defined as SAS score 4.


Secondary Outcome Measures:
  • Percentage of patients with agitation and receiving additional sedatives. [ Time Frame: During the first 24 hours postoperatively ] [ Designated as safety issue: No ]
    Agitation is defined as SAS above 4. Patients are given midazolam as agitation.


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


Estimated Enrollment: 170
Study Start Date: October 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445639

Contacts
Contact: Jian-Xin Zhou, MD 8610 67098019 zhoujx.cn@gmail.com

Locations
China, Beijing
Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Jian-Xin Zhou, MD     8610 67098019     zhoujx.cn@gmail.com    
Sponsors and Collaborators
Capital Medical University
Investigators
Study Chair: Jian-Xin Zhou, MD Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University
  More Information

No publications provided

Responsible Party: Jian-Xin Zhou, Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT01445639     History of Changes
Other Study ID Numbers: BTH-NICU-2011-02, 2009-03-28
Study First Received: September 30, 2011
Last Updated: October 22, 2012
Health Authority: China: Ministry of Health

Keywords provided by Capital Medical University:
dexmedetomidine
sedation
neurosurgery
postoperative care

Additional relevant MeSH terms:
Central Nervous System Diseases
Nervous System Diseases
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
 Analgesics
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

ClinicalTrials.gov processed this record on May 16, 2013