Dexmedetomidine in Patients After Intracranial Surgery
Use of Dexmedetomidine for Prophylactic Analgesia and Sedation in Patients After Intracranial Surgery (Prophylactic Analgesia and Sedation Trial, PASTrial)
2 other identifiers
interventional
192
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedFirst Posted
Study publicly available on registry
October 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedJanuary 28, 2014
January 1, 2014
1.2 years
September 30, 2011
January 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean percentage of hours of optimal sedation.
Optimal sedation is defined as SAS score 4.
24 hours postoperative
Secondary Outcomes (1)
Percentage of patients with agitation and receiving additional sedatives.
During the first 24 hours postoperatively
Other Outcomes (1)
Percentage of patients with adverse events.
During the first 24 hours postoperatively
Study Arms (2)
Dexmedetomidine group
EXPERIMENTALPlacebo group
PLACEBO COMPARATORInterventions
Intravenous infusion at rate of 0.4μg/kg/h, during the first 24 hours postoperatively
Eligibility Criteria
You may qualify if:
- Adult patients after intracranial surgery with delayed extubation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jian-Xin Zhou, MD
Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 30, 2011
First Posted
October 4, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2012
Study Completion
February 1, 2013
Last Updated
January 28, 2014
Record last verified: 2014-01