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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01445639

Enrollment

192

Registered

2011-10-04

Start date

2011-10-31

Completion date

2013-02-28

Last updated

2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Diseases

Keywords

dexmedetomidine, sedation, neurosurgery, postoperative care

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.

Detailed description

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.

Interventions

DRUGDexmedetomidine

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

DRUGNormal saline

as placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Mean percentage of hours of optimal sedation.	24 hours postoperative	Optimal sedation is defined as SAS score 4.

Secondary

Measure	Time frame	Description
Percentage of patients with agitation and receiving additional sedatives.	During the first 24 hours postoperatively	Agitation is defined as SAS above 4. Patients are given midazolam as agitation.

Other

Measure	Time frame	Description
Percentage of patients with adverse events.	During the first 24 hours postoperatively	Adverse events include hypotension, bradycardia, airway obstruction, apnea, and consciousness disorders

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026