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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Adjunct Dexmedetomidine Therapy Impact on Sedative and Analgesic

Conditions
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Sedation, Analgesia

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Low dose dexmedetomidine<br>Dexmedetomidine 0.2 mcg/kg/hr added to fentanyl & propofol. | Drug: Dexmedetomidine<br>* IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days<br>* Other names: Precedex;|
| Experimental: 2. High dose dexmedetomidine<br>Dexmedetomidine 0.6 mcg/kg/hr added to fentanyl & propofol. | Drug: Dexmedetomidine<br>* IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days<br>* Other names: Precedex;|
| Placebo Comparator: 3. Placebo<br>Placebo added to fentanyl & propofol. | Drug: Dexmedetomidine<br>* IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days<br>* Other names: Precedex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total daily dose of fentanyl and propofol |  | Daily | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total ventilation time |  | Study ended | 
| ICU length of stay |  | Study ended. | 
| Hospital length of stay |  | Study ended | 
| Patient outcomes/mortality |  | Study ended. | 
| Total pharmacy expenditures |  | Study ended. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanical ventilation