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Dexmedetomidine in Patients After Intracranial Surgery

Primary Purpose

Central Nervous System Diseases

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Dexmedetomidine

Normal saline

About this trial

This is an interventional treatment trial for Central Nervous System Diseases focused on measuring dexmedetomidine, sedation, neurosurgery, postoperative care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine group

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

Mean percentage of hours of optimal sedation.

Optimal sedation is defined as SAS score 4.

Secondary Outcome Measures

Percentage of patients with agitation and receiving additional sedatives.

Agitation is defined as SAS above 4. Patients are given midazolam as agitation.

Full Information

NCT ID

NCT01445639

First Posted

September 30, 2011

Last Updated

January 25, 2014

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT01445639

Brief Title

Dexmedetomidine in Patients After Intracranial Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Nervous System Diseases

Keywords

dexmedetomidine, sedation, neurosurgery, postoperative care

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

192 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dexmedetomidine group

Arm Type

Experimental

Arm Title

Placebo group

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Normal saline

Intervention Description

as placebo

Primary Outcome Measure Information:

Title

Mean percentage of hours of optimal sedation.

Description

Optimal sedation is defined as SAS score 4.

Time Frame

24 hours postoperative

Secondary Outcome Measure Information:

Title

Percentage of patients with agitation and receiving additional sedatives.

Description

Agitation is defined as SAS above 4. Patients are given midazolam as agitation.

Time Frame

During the first 24 hours postoperatively

Other Pre-specified Outcome Measures:

Title

Percentage of patients with adverse events.

Description

Adverse events include hypotension, bradycardia, airway obstruction, apnea, and consciousness disorders

Time Frame

During the first 24 hours postoperatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jian-Xin Zhou, MD

Organizational Affiliation

Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University

Official's Role

Study Chair

Facility Information:

Facility Name

Neuro-ICU, Beijing Tiantan Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100050

Country

China

12. IPD Sharing Statement

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Dexmedetomidine in Patients After Intracranial Surgery

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