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

Analgesia Clinical Trial

Official title:

Adjunct Dexmedetomidine Therapy Impact on Sedative and Analgesic

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00852046
• Other study ID #: #2008.071
• Status: Withdrawn
• Phase: Phase 4
• First received: February 24, 2009
• Last updated: October 5, 2011
• Start date: February 2009
• Est. completion date: March 2009

Study information

• Verified date: July 2011
• Source: Avera McKennan Hospital & University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia
• Sedation

Intervention

Drug:
• Dexmedetomidine
IV solution, 0.2 mcg/kg/hr or 0.6 mcg/kg/hr for a max of 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Avera McKennan Hospital & University Health Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total daily dose of fentanyl and propofol		Daily	No
Secondary	Total ventilation time		Study ended	No
Secondary	ICU length of stay		Study ended.	No
Secondary	Hospital length of stay		Study ended	No
Secondary	Patient outcomes/mortality		Study ended.	Yes
Secondary	Total pharmacy expenditures		Study ended.	No