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

Adjunct Dexmedetomidine Therapy Impact on Sedative and Analgesic

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.

Study Overview

• Status: Withdrawn
• Conditions: Analgesia; Sedation
• Intervention / Treatment: Drug: Dexmedetomidine

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
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Precedex

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Avera McKennan Hospital & University Health Center
• Investigators: Principal Investigator: John A Kappes, Pharm.D., Avera McKennan Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: February 24, 2009
• First Submitted That Met QC Criteria: February 25, 2009
• First Posted (Estimate): February 26, 2009

Study Record Updates

• Last Update Posted (Estimate): October 6, 2011
• Last Update Submitted That Met QC Criteria: October 5, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Mechanical ventilation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: #2008.071