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Acute Neurological ICU Sedation Trial (ANIST)
This study has been completed.
Sponsored by: Johns Hopkins University
Information provided by: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00390871
  Purpose

Dexmedetomidine (Precedex, Hospira) is a "super" selective alpha2-agonist - 8-10x more avid binding to alpha2 receptors than clonidine - and may have particularly favorable characteristics as a continuous i.v. infusion sedative for critically ill neuroscience patients. Its combination of anxiolysis, analgesia, without undue lethargy may make it an ideal agent where frequent neurological examinations are important (12). Unclear, however, is whether Precedex is superior to current common i.v. sedation protocols, and if there are any undue concerns of this agent on cerebral physiology and cortical stimulation.


Condition Intervention Phase
Sedation
Drug: Precedex
Drug: Propofol
Phase II

Drug Information available for: Propofol Dexmedetomidine Dexmedetomidine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Acute Neurological ICU Sedation Trial (ANIST)

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Johns Hopkins Adapted Cognitive Exam
  • Confusion Assessment Method for the Intensive Care Unit
  • Time from initiation of study drug to calm, non-anxious state
  • ICP
  • CPP
  • O2 extraction via jugular bulb catheter (SjO2) or cerebral tissue oximeter
  • Cerebral blood flow (CBF) in a subset of patients.
  • Elicitation and quantification of spike or spike-wave complexes

Secondary Outcome Measures:
  • Therapy Intensity Level Scale (TIL)
  • Requirement for fluids, pressors
  • Toxicity/side effects
  • Numerical Pain Rating Scale
  • Need for less or more fentanyl during the infusion drug phase
  • Differences in sedation between Precedex and propofol in patients with known seizure disorder.

Enrollment: 60
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Study 1: Inclusion Criteria:

Neuroscience patients in the NCCU who are:

  1. 18-80 years of age;
  2. Mechanically ventilated patients;
  3. Requiring continuous sedation for a minimum of 9-11 hours (depending on whether or not pt is post-operative), yet frequent neurological examinations or Patients with a NICSS score > 0
  4. Patient or family able to provide consent.
  5. Considered to have guarded yet stable neurological state. Not fluctuating intracranial pressure (ICP), cerebral perfusion pressure (CPP), or ongoing known cerebral ischemia if ICP monitoring in place.

Study 1: Exclusion Criteria:

  1. Pregnancy.
  2. ICP> 30 mm Hg despite therapy if ICP monitored.
  3. CPP <70 mm Hg if monitored.
  4. Occurrence of: new cerebral stroke, hemorrhage, or change in edema by CT, increase in ICP if monitored.
  5. Neuromuscular paralysis.
  6. Non-functional cognitive exam - not following commands.
  7. Renal insufficiency: Serum Creatinine >2.0 mg/dl or estimated Cr Clearance <40.0 ml/min.
  8. Hepatic disease: AST, ALT > 300, or INR > 1.7 not on anticoagulants.
  9. Severe COPD with baseline arterial pCO2>50.
  10. Suspected alcohol or substance withdrawal.
  11. Hypotension - requiring pressor therapy to maintain baseline adequate CPP or mean arterial pressure.
  12. Cardiac arrhythmia - sinus bradycardia (HR <60), atrial fibrillation (>6 PVC's/min)
  13. Bradycardia- heart rate less than 60 beats per minute.
  14. Patient does not require mechanical ventilation.

Study 2: Inclusion Criteria:

Critically ill neuroscience patients who are:

  1. 18-80 years of age;
  2. Mechanically ventilated;
  3. Require Intracranial Pressure (ICP) monitoring by either subarachnoid bolt (SA bolt), or by an Intra-Ventricular Catheter (IVC).
  4. Amenable for placement of intra-cerebral oxygen sensor or jugular bulb catheter.
  5. Have GCS score > 5 that requires sedation.
  6. Requiring continuous sedation for minimum of 9-11 hours (depending on whether or not pt is post-operative) , yet frequent neurological examinations every 1-2 hours or Patients with a NICSS score > 0
  7. Patient or family able to provide consent.

Study 2: Exclusion Criteria:

  1. Pregnancy;
  2. ICP> 30 mm Hg despite therapy;
  3. CPP <70 mm Hg;
  4. Occurrence of: new cerebral stroke, hemorrhage, or change in edema by CT, increase in ICP if monitored.
  5. Continuous neuromuscular paralysis
  6. Renal insufficiency: Serum Creatinine >2.0 mg/dl or estimated Cr <40.0 Clearance ml/min.
  7. Hepatic disease: AST, ALT > 300, or INR > 1.7 not on anticoagulants.
  8. Severe COPD with baseline arterial pCO2>50.
  9. Suspected alcohol or substance withdrawal.

Study 3: Inclusion Criteria:

Critically ill neuroscience patients who are:

  1. 18-80 years of age;
  2. Requiring continuous sedation for minimum of 9-11 hrs (depending on whether or not pt is post-operative), yet frequent neurological examinations or Patients with a NICSS score >0
  3. Patient or family able to provide consent.
  4. Mechanically ventilated patients;
  5. Considered to have guarded yet stable neurological state. Not fluctuating ICP, CPP, or ongoing known cerebral ischemia.
  6. Presence of intra-operatively placed GRID electrode array or patients requiring continuous EEG monitoring.

Study 3: Exclusion Criteria:

  1. Pregnancy
  2. Occurrence of: new cerebral stroke, hemorrhage, or change in edema by CT, increase in ICP if monitored.
  3. Continuous neuromuscular paralysis
  4. Renal insufficiency: Serum Creatinine >2.0 or Cr Clearance <40.0
  5. Hepatic insufficiency: AST, ALT> 300, or PT time > 1.7 not on anticoagulants.
  6. Severe COPD with baseline arterial pCO2>50.
  7. Suspected alcohol or substance withdrawal.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00390871

Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Marek Mirski, MD, PhD Johns Hopkins University
  More Information

Study ID Numbers: ANIST
Study First Received: October 19, 2006
Last Updated: March 31, 2008
ClinicalTrials.gov Identifier: NCT00390871  
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Patient
Must be
Under

Study placed in the following topic categories:
Dexmedetomidine
Propofol

ClinicalTrials.gov processed this record on January 15, 2009