A Phase 4 interventional study of Dexmedetomidine and Normal saline in Central Nervous System Diseases, sponsored by Capital Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-28.
Sponsored by Capital Medical University · Phase 4, Interventional, and Treatment
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.
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.
974 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.
This study's enrollment of 192 is above the median of 48 across 623 interventional studies indexed under Nervous System Diseases.
Browse Nervous System Diseases studies →Capital Medical University is the lead sponsor of 283 studies on the registry; 92 are open to participants now.
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Exclusion Criteria:
Drug: Dexmedetomidine
Drug: Normal saline
Intravenous infusion at rate of 0.4μg/kg/h, during the first 24 hours postoperatively
as placebo
Mean percentage of hours of optimal sedation.
Optimal sedation is defined as SAS score 4.
Time frame: 24 hours postoperative
Percentage of patients with agitation and receiving additional sedatives.
Agitation is defined as SAS above 4. Patients are given midazolam as agitation.
Time frame: During the first 24 hours postoperatively
Percentage of patients with adverse events.
Adverse events include hypotension, bradycardia, airway obstruction, apnea, and consciousness disorders
Time frame: During the first 24 hours postoperatively
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Capital Medical University