Dexmedetomidine in Patients After Intracranial Surgery

Capital Medical University192 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

192

Conditions

Central Nervous System Diseases

Interventions

DexmedetomidineDRUG

Intravenous infusion at rate of 0.4μg/kg/h, during the first 24 hours postoperatively

Normal salineDRUG

as placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Mean percentage of hours of optimal sedation.

Optimal sedation is defined as SAS score 4.

Time frame: 24 hours postoperative

Secondary Outcomes

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

Data from ClinicalTrials.gov

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