Dexmedetomidine in Patients After Intracranial Surgery
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.
Central Nervous System Diseases
Drug: Normal saline
|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)|
- 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.
- 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.
- 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
|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)|
|Experimental: Dexmedetomidine group||
Intravenous infusion at rate of 0.4μg/kg/h, during the first 24 hours postoperatively
|Placebo Comparator: Placebo group||
Drug: Normal saline
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.
|Contact: Jian-Xin Zhou, MD||8610 firstname.lastname@example.org|
|Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100050|
|Contact: Jian-Xin Zhou, MD 8610 67098019 email@example.com|
|Study Chair:||Jian-Xin Zhou, MD||Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University|