Status:
COMPLETED
GPI 15715 For Sedation in the Intensive Care Unit (ICU) Setting
Lead Sponsor:
Eisai Inc.
Conditions:
Postoperative Sedation
Intubation
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 respons...
Detailed Description
Patients who are intubated and ventilated and will require up to 8 hours of sedation in the ICU are eligible for participation in this study. Patients will be randomized to receive 1 of 3 treatments. ...
Eligibility Criteria
Inclusion
- Require 2 to 8 hours of intubation and mechanical ventilation following elective surgery
- American Society of Anesthesiologists (ASA) status of I-IV
Exclusion
- Requires emergency agency
- Requires neuromuscular blockers during sedation
- Requires use of epidural drug administration during sedation
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
May 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00125398
Start Date
July 1 2005
End Date
May 1 2007
Last Update
November 7 2008
Active Locations (17)
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1
St. Mary's Hospital
Rogers, Arizona, United States, 72756
2
Jackson Memorial Hospital
Miami, Florida, United States, 33136
3
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
4
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242