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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| obese subjects | BMI > 35 |
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| Measure | Description | Time Frame |
|---|---|---|
| A change in mean arterial pressure (MAP) of 20% or more from baseline | during upper endoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Episodes of bradycardia - pulse less than 50 | during upper endoscopy | |
| ECG changes consistent with myocardial ischemia | during upper endoscopy | |
| Decrease in respiratory rate - change of 20% or more from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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The research subjects will be selected from a private practice.
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence B Cohen, MD | Research Associates of New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Associates of New York | New York | New York | 10075 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. | after all patients completed |
| Compare the level of sedation between the obese and non-obese cohorts | after all patients completed |
| compare patient satisfaction with endoscopic sedation in obese and non-obese cohorts | after all patients completed |
| Compare time to sedation in the obese and non-obese cohorts | after all patients completed |
| Oxygen desaturation | during upper endoscopy |
| Apneic episodes | during upper endoscopy |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |