GPI 15715 For Sedation in the Intensive Care Unit (ICU) Setting

Completed · Phase 2

Conditions studied: Postoperative Sedation, Intubation, Respiration, Artificial

In brief

Patients who are in the intensive care unit after surgery and require mechanical breathing support (intubation and ventilation) usually require sedation to avoid agitation and excessive stress responses. Short-acting sedatives such as midazolam and propofol are the drugs typically used for this. Propofol provides for fast sedation and fast recovery from sedation. Midazolam is slower to sedation and slower for recovery, but may provide some advantages over propofol, such as a lower incidence of hypotension (low blood pressure). This study will look at propofol compared to a product with fast sedation and recovery like that of propofol but with less of a chance for hypotension like with midazolam. Patients will be treated with the product for up to 8 hours and then will be monitored for 8 hours following treatment.

Key facts

Study ID

NCT00125398

Run by

Eisai Inc.

People needed

60

Starts

2005-07-01

Expected to finish

2007-05-01

Last updated by the study team

2008-11-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Require 2 to 8 hours of intubation and mechanical ventilation following elective surgery
• American Society of Anesthesiologists (ASA) status of I-IV

You may not qualify if…

• Requires emergency agency
• Requires neuromuscular blockers during sedation
• Requires use of epidural drug administration during sedation

Where it is running

• St. Mary's Hospital — Rogers, Arizona, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• Advocate Lutheran General Hospital — Park Ridge, Illinois, United States
• University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
• Central Maine Pulmonary Associates — Auburn, Maine, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Cooper University Hospital — Camden, New Jersey, United States
• Long Island Jewish Medical Center — New Hyde Park, New York, United States
• New York University School of Medicine — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Oklahoma University Medical Center — Oklahoma City, Oklahoma, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Department of Veterans Affairs, North Texas Health Care System — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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