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

Avera McKennan Hospital & University Health Center

Status and phase: Withdrawn; Phase 4

Conditions: Sedation; Analgesia

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT00852046

#2008.071

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups, including a placebo group

1. Low dose dexmedetomidine

Experimental group

Description:

Dexmedetomidine 0.2 mcg/kg/hr added to fentanyl \& propofol.

Treatment:

Drug: Dexmedetomidine

2. High dose dexmedetomidine

Experimental group

Description:

Dexmedetomidine 0.6 mcg/kg/hr added to fentanyl \& propofol.

Treatment:

Drug: Dexmedetomidine

3. Placebo

Placebo Comparator group

Description:

Placebo added to fentanyl \& propofol.

Treatment:

Drug: Dexmedetomidine