Intubation Clinical Trial
Official title:
A Phase II, Randomized, Open-Label Study to Examine the Safety and Efficacy of GPI 15715 for Sedation of Patients Requiring Intubation and Mechanical Ventilation in the Intensive Care Unit Setting
Verified date | November 2008 |
Source | Eisai Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Require 2 to 8 hours of intubation and mechanical ventilation following elective surgery 2. American Society of Anesthesiologists (ASA) status of I-IV Exclusion Criteria: 1. Requires emergency agency 2. Requires neuromuscular blockers during sedation 3. Requires use of epidural drug administration during sedation |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Central Maine Pulmonary Associates | Auburn | Maine |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Cooper University Hospital | Camden | New Jersey |
United States | Department of Veterans Affairs, North Texas Health Care System | Dallas | Texas |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of Iowa Hospital and Clinics | Iowa City | Iowa |
United States | Jackson Memorial Hospital | Miami | Florida |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | Long Island Jewish Medical Center | New Hyde Park | New York |
United States | Mount Sinai School of Medicine | New York | New York |
United States | New York University School of Medicine | New York | New York |
United States | Oklahoma University Medical Center | Oklahoma City | Oklahoma |
United States | Advocate Lutheran General Hospital | Park Ridge | Illinois |
United States | St. Mary's Hospital | Rogers | Arizona |
United States | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Eisai Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability of infusions | |||
Secondary | Percentage of patients requiring rescue medications | |||
Secondary | Evaluation of the onset of effect | |||
Secondary | Evaluation of satisfaction with sedation | |||
Secondary | Determination of pharmacokinetic (PK) levels of GPI 15715 in blood |
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