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Adjunct Dexmedetomidine (Precedex®) Therapy Impact on Sedative and Analgesic Requirement

This study has been withdrawn prior to enrollment.
(PI resigned.)
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT00852046
First received: February 24, 2009
Last updated: October 5, 2011
Last verified: July 2011
History of Changes
  Purpose

Assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.


Condition Intervention Phase
Sedation
Analgesia
 Drug: Dexmedetomidine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Adjunct Dexmedetomidine Therapy Impact on Sedative and Analgesic

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Avera McKennan Hospital & University Health Center:

Primary Outcome Measures:
  • Total daily dose of fentanyl and propofol [ Time Frame: Daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total ventilation time [ Time Frame: Study ended ] [ Designated as safety issue: No ]
  • ICU length of stay [ Time Frame: Study ended. ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: Study ended ] [ Designated as safety issue: No ]
  • Patient outcomes/mortality [ Time Frame: Study ended. ] [ Designated as safety issue: Yes ]
  • Total pharmacy expenditures [ Time Frame: Study ended. ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. Low dose dexmedetomidine
Dexmedetomidine 0.2 mcg/kg/hr added to fentanyl & propofol.
 Drug: Dexmedetomidine
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
Other Name: Precedex
Experimental: 2. High dose dexmedetomidine
Dexmedetomidine 0.6 mcg/kg/hr added to fentanyl & propofol.
 Drug: Dexmedetomidine
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
Other Name: Precedex
Placebo Comparator: 3. Placebo
Placebo added to fentanyl & propofol.
 Drug: Dexmedetomidine
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days
Other Name: Precedex

Detailed Description:

Patients identified by selection criteria within 48 hours of intubation will be randomly assigned to one of three study arms: dexmedetomidine 0.2 mcg/kg/hr, dexmedetomidine 0.6 mcg/kg/hr, or placebo. If not already on, patients will be converted to propofol and fentanyl for sedation and analgesia, which will be titrated to a goal SAS score of 3-4.

Patients will be monitored, assessed, and evaluated by all regular policies and procedures of the institution. Extubation will be at the discretion of the physicians and medical team caring for the patient. If the patient is still intubated at five days study drug will then be stopped and further use of dexmedetomidine will be at the discretion of the physicians.

Primary objective will assess impact of increasing dose of dexmedetomidine on total daily dose of fentanyl and propofol while maintaining sedation in a mechanically ventilated patient in a general medical intensive care unit.

Secondary objectives include total ventilation time, ICU length of stay, hospital length of stay, patient outcomes/mortality, and total pharmacy expenditures.

  Eligibility

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

Inclusion Criteria:

  • surgical, medical, or trauma patients requiring sedation for mechanical ventilation
  • age 18-80
  • Anticipated ventilation time of > 24 hrs
  • Reasonable chance of recovery

Exclusion Criteria:

  • Severe COPD
  • Chronic immunosuppression (equivalent to prednisone 7.5 mg daily or higher)
  • Heart block
  • Bradycardia
  • Significant head injury
  • Goal SAS score of 1-2
  • Severe hepatic impairment
  • Hypertriglyceridemia
  • Allergy to dexmedetomidine, fentanyl, propofol or eggs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852046

Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
Principal Investigator: John A Kappes, Pharm.D. Avera McKennan Hospital
  More Information

No publications provided

Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT00852046     History of Changes
Other Study ID Numbers: #2008.071
Study First Received: February 24, 2009
Last Updated: October 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Avera McKennan Hospital & University Health Center:
Mechanical ventilation

Additional relevant MeSH terms:
Analgesics
Dexmedetomidine
Hypnotics and Sedatives
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Central Nervous System Depressants
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013