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.
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.
Study Type
OBSERVATIONAL
Enrollment
65
Research Associates of New York
New York, New York, United States
A change in mean arterial pressure (MAP) of 20% or more from baseline
Time frame: during upper endoscopy
Episodes of bradycardia - pulse less than 50
Time frame: during upper endoscopy
ECG changes consistent with myocardial ischemia
Time frame: during upper endoscopy
Decrease in respiratory rate - change of 20% or more from baseline
Time frame: during upper endoscopy
Assess the dose of propofol, midazolam, and fentanyl necessary to achieve adequate sedation during upper endoscopy and compare the dose requirements of the obese and non-obese patient cohorts.
Time frame: after all patients completed
Compare the level of sedation between the obese and non-obese cohorts
Time frame: after all patients completed
compare patient satisfaction with endoscopic sedation in obese and non-obese cohorts
Time frame: after all patients completed
Compare time to sedation in the obese and non-obese cohorts
Time frame: after all patients completed
Oxygen desaturation
Time frame: during upper endoscopy
Apneic episodes
Time frame: during upper endoscopy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.