Effect of Bispectral Index (BIS) Titrated Propofol Sedation on Lower Esophageal Sphincter Pressures and Esophageal Function in Intensive Care Patients
Stopped early · Not applicable
Conditions studied: Respiration, Artificial
In brief
Eligible patients will be allocated to receive propofol sedation titrated to 3 different Bispectral Index (BIS) levels in a random order. Primary hypothesis: Deepening propofol sedation - as determined by BIS - lowers esophageal pressure in critical care patients.
Key facts
- Study ID
- NCT01173263
- Run by
- The Cleveland Clinic
- People needed
- 1
- Starts
- 2010-07-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2014-03-05
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18-80 years of age
- Written informed consent from relatives
- Clinically stable
- Mechanically ventilated < 2days
- Require sedation and expected to be given propofol
You may not qualify if…
- Recent injury or other pathologic condition of the esophagus
- Major bronchopleural fistula
- History of liver failure
- History of renal failure
- History of major neuromuscular disease
- Multiple trauma
- Upper motor nerve injury
- Hypersensitivity to propofol
- Recent gastrointestinal surgery
- Patients with a diagnosed or suspected condition that may give false results in BIS monitoring.
- Tracheostomized patients
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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