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Sponsored by: |
Research Associates of New York, LLP |
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Information provided by: | Research Associates of New York, LLP |
ClinicalTrials.gov Identifier: | NCT00782873 |
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.
Condition |
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Obesity |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients: Assessment of Cardiopulmonary Parameters |
Enrollment: | 65 |
Study Start Date: | March 2008 |
Study Completion Date: | September 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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obese subjects
BMI > 35
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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. 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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
The research subjects will be selected from a private practice.
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Research Associates of New York | |
New York, New York, United States, 10075 |
Principal Investigator: | Lawrence B Cohen, MD | Research Associates of New York |
Responsible Party: | Research Associates Of New York ( Lawrence B. Cohen, MD ) |
Study ID Numbers: | 424-02-08 |
Study First Received: | October 29, 2008 |
Last Updated: | October 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00782873 History of Changes |
Health Authority: | United States: Institutional Review Board |
propofol sedation safety obesity |
Anesthetics, Intravenous Body Weight Signs and Symptoms Obesity Anesthetics, General Hypnotics and Sedatives |
Central Nervous System Depressants Anesthetics Nutrition Disorders Overweight Overnutrition Propofol |
Anesthetics, Intravenous Obesity Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Overweight Pharmacologic Actions Body Weight |
Signs and Symptoms Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Nutrition Disorders Overnutrition Propofol Central Nervous System Agents |