ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00852046
Recruitment Status : Withdrawn (PI resigned.)
First Posted : February 26, 2009
Last Update Posted : October 6, 2011
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center

Brief Summary:
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 or disease Intervention/treatment Phase
Sedation Analgesia Drug: Dexmedetomidine Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Adjunct Dexmedetomidine Therapy Impact on Sedative and Analgesic
Study Start Date : February 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Total daily dose of fentanyl and propofol [ Time Frame: Daily ]

Secondary Outcome Measures :
  1. Total ventilation time [ Time Frame: Study ended ]
  2. ICU length of stay [ Time Frame: Study ended. ]
  3. Hospital length of stay [ Time Frame: Study ended ]
  4. Patient outcomes/mortality [ Time Frame: Study ended. ]
  5. Total pharmacy expenditures [ Time Frame: Study ended. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852046


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

Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT00852046     History of Changes
Other Study ID Numbers: #2008.071
First Posted: February 26, 2009    Key Record Dates
Last Update Posted: October 6, 2011
Last Verified: July 2011

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

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