Dexmedetomidine in Patients After Intracranial Surgery

Central Nervous System Diseases Clinical Trial

Official title:

Use of Dexmedetomidine for Prophylactic Analgesia and Sedation in Patients After Intracranial Surgery (Prophylactic Analgesia and Sedation Trial, PASTrial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01445639
• Other study ID #: BTH-NICU-2011-02
• Secondary ID: 2009-03-28
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2011
• Last updated: January 25, 2014
• Start date: October 2011
• Est. completion date: February 2013

Study information

• Verified date: January 2014
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: February 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Nervous System Diseases

Intervention

Drug:
• Dexmedetomidine
Intravenous infusion at rate of 0.4µg/kg/h, during the first 24 hours postoperatively
• Normal saline
as placebo

Locations

Country	Name	City	State
China	Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of patients with adverse events.	Adverse events include hypotension, bradycardia, airway obstruction, apnea, and consciousness disorders	During the first 24 hours postoperatively	Yes
Primary	Mean percentage of hours of optimal sedation.	Optimal sedation is defined as SAS score 4.	24 hours postoperative	No
Secondary	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	No