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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-03-28 | Other Grant/Funding Number | Beijing Municipal Health Bureau, Beijing, China |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Intravenous infusion at rate of 0.4μg/kg/h, during the first 24 hours postoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean percentage of hours of optimal sedation. | Optimal sedation is defined as SAS score 4. | 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with agitation and receiving additional sedatives. | Agitation is defined as SAS above 4. Patients are given midazolam as agitation. | During the first 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with adverse events. | Adverse events include hypotension, bradycardia, airway obstruction, apnea, and consciousness disorders | During the first 24 hours postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian-Xin Zhou, MD | Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Normal saline | Drug | as placebo |
|
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |