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)

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.

Study Overview

• Status: Completed
• Conditions: Central Nervous System Diseases
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Normal saline; as placebo
Experimental: Dexmedetomidine group	Drug: Dexmedetomidine; Intravenous infusion at rate of 0.4μg/kg/h, during the first 24 hours postoperatively

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Study Chair: Jian-Xin Zhou, MD, Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: September 30, 2011
• First Submitted That Met QC Criteria: September 30, 2011
• First Posted (Estimate): October 4, 2011

Study Record Updates

• Last Update Posted (Estimate): January 28, 2014
• Last Update Submitted That Met QC Criteria: January 25, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: dexmedetomidine; sedation; neurosurgery; postoperative care
• Additional Relevant MeSH Terms: Nervous System Diseases; Central Nervous System Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: BTH-NICU-2011-02; 2009-03-28 (Other Grant/Funding Number: Beijing Municipal Health Bureau, Beijing, China)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No