Acute Neurological ICU Sedation Trial (ANIST)

NCT00390871 | Completed Phase 2

• 1 other identifier: ANIST
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sedation

Outcome Measures

Primary Outcomes (3)

• Johns Hopkins Adapted Cognitive Exam

  Cognitive assessment tool

  day of study

• Confusion Assessment Method (CAM) for the Intensive Care Unit

  CAM-ICU delirium assessment tool

  day of study

• Time from initiation of study drug to calm, non-anxious state

  From control state to RASS Score or 0 to -1 (average=137 min)

  day of study

Secondary Outcomes (5)

• Therapy Intensity Level Scale (TIL)

  day of study

• Requirement for fluids, pressors

  day of study

• Toxicity/side effects

  day of study

• Numerical Pain Rating Scale

  day of study

• Need for less or more fentanyl during the infusion drug phase

  day of study

Study Arms (2)

Fentanyl/Propofol sedation first

ACTIVE COMPARATOR

Patient given fentanyl only first, then sedated with fentanyl/propofol as needed to have Richmond Agitation Sedation Scale (RASS) Score 0 to -1. After washout with fentanyl only, patient sedated with fentanyl/dexmedetomidine to have RASS Score 0 to -1.

Drug: Fentanyl/Dexmedetomidine; Drug: Fentanyl/Propofol; Drug: Fentanyl

Fentanyl/Dexmedetomidine sedation first

ACTIVE COMPARATOR

Patient given fentanyl only first, then sedated with fentanyl/dexmedetomidine as needed to have RASS Score 0 to -1. After washout with fentanyl only, patient sedated with fentanyl/propofol to have RASS Score 0 to -1.

Drug: Fentanyl/Dexmedetomidine; Drug: Fentanyl/Propofol; Drug: Fentanyl

Interventions

Fentanyl/Dexmedetomidine DRUG

Also known as: Precedex

Fentanyl/Dexmedetomidine sedation first; Fentanyl/Propofol sedation first

Fentanyl/Propofol DRUG

Also known as: Diprivan

Fentanyl/Dexmedetomidine sedation first; Fentanyl/Propofol sedation first

Fentanyl DRUG

Fentanyl/Dexmedetomidine sedation first; Fentanyl/Propofol sedation first

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Critically ill neuroscience patients who are:

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• Lewin JJ 3rd, LeDroux SN, Shermock KM, Thompson CB, Goodwin HE, Mirski EA, Gill RS, Mirski MA. Validity and reliability of The Johns Hopkins Adapted Cognitive Exam for critically ill patients. Crit Care Med. 2012 Jan;40(1):139-44. doi: 10.1097/CCM.0b013e31822ef9fc.

  PMID: 21926576 RESULT

MeSH Terms

Interventions

Fentanyl; Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Marek Mirski, MD, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2006
• First Posted: October 20, 2006
• Study Start: May 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)