Acute Neurological ICU Sedation Trial (ANIST)

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daniel Hanley; Johns Hopkins University
• Treatments: Dexmedetomidine; Fentanyl; Propofol

Criteria

Objective 1: Inclusion Criteria:

Neuroscience patients in the Neuro Critical Care Unit (NCCU) who are:

• 18-80 years of age;

• Mechanically ventilated patients;

• 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 Nursing Instrument for Communication of Sedation Score (NICSS) > 0

• Patient or family able to provide consent.

• 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.

Objective 1: Exclusion Criteria:

• Pregnancy.

• ICP> 30 mm Hg despite therapy if ICP monitored.

• CPP <70 mm Hg if monitored.

• Occurrence of: new cerebral stroke, hemorrhage, or change in edema by CT, increase in ICP if monitored.

• Neuromuscular paralysis.

• Non-functional cognitive exam - not following commands.

• Renal insufficiency: Serum Creatinine >2.0 mg/dl or estimated Cr Clearance <40.0 ml/min.

• Hepatic disease: aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 300, or international normalized ratio (INR) > 1.7 not on anticoagulants.

• Severe chronic obstructive pulmonary disease (COPD) with baseline arterial partial pressure of carbon dioxide (pCO2)>50.

• Suspected alcohol or substance withdrawal.

• Hypotension - requiring pressor therapy to maintain baseline adequate CPP or mean arterial pressure (MAP).

• Cardiac arrhythmia - sinus bradycardia (HR <60), atrial fibrillation (>6 PVC's/min)

• Bradycardia- heart rate less than 60 beats per minute.

• Patient does not require mechanical ventilation.

Objective 2: Inclusion Criteria:

Critically ill neuroscience patients who are:

• 18-80 years of age;

• Mechanically ventilated;

• Require Intracranial Pressure (ICP) monitoring by either subarachnoid bolt (SA bolt), or by an Intra-Ventricular Catheter (IVC).

• Amenable for placement of intra-cerebral oxygen sensor or jugular bulb catheter.

• Have glaucoma coma score (GCS) score > 5 that requires sedation.

• 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

• Patient or family able to provide consent.

Objective 2: Exclusion Criteria:

• Pregnancy;

• ICP> 30 mm Hg despite therapy; 3) CPP <70 mm Hg;

• Occurrence of: new cerebral stroke, hemorrhage, or change in edema by CT, increase in ICP if monitored.

• Continuous neuromuscular paralysis

• Renal insufficiency: Serum Creatinine >2.0 mg/dl or estimated Cr <40.0 Clearance ml/min.

• Hepatic disease: AST, ALT > 300, or INR > 1.7 not on anticoagulants.

• Severe COPD with baseline arterial pCO2>50.

• Suspected alcohol or substance withdrawal.