NCT00782873

Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients

Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients: Assessment of Cardiopulmonary Parameters

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Research Associates of New York, LLP · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety of propofol-based, gastroenterologist-administered sedation in severely obese patients (BMI≥35) undergoing upper endoscopy. The investigators aim to test the hypothesis that it is safe to use balanced-propofol, gastroenterologist-administered sedation in obese patients.

Detailed description

The purpose of this study is to evaluate the safety of propofol-based, gastroenterologist-administered sedation in severely obese patients (BMI≥35) undergoing upper endoscopy. We will use changes in pulmonary and hemodynamic parameters as the primary safety measure in this study. We will compare these results in 30 non-obese patients and in 30 obese patients. The term balanced propofol sedation refers to using a low dose of propofol in combination with small amounts of an opioid and midazolam.

Conditions

• Obesity

Timeline

• Start date: 2008-03-01
• Primary completion: 2008-08-01
• Completion: 2008-09-01
• First posted: 2008-10-31
• Last updated: 2008-10-31

Locations

1 site across 1 country: United States