Obesity
Conditions
Keywords
propofol, sedation, safety, obesity
Brief 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.
Interventions
None listed
Sponsors
Research Associates of New York, LLP
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Undergoing an endoscopic esophagostroduodenoscopy (EGD) * Capable of providing written informed consent and willing and able to comply with all procedures of the study * Adults between the ages of 18 and 85 inclusive (and of legal age to consent) * ASA score of I, II, or III
Exclusion criteria
* Severe acute illness that is not resolved or stabilized prior to enrollment. Study entry will be based on the investigator's judgment * Need for sleep or narcotic analgesic medication on a continuous basis during the proceeding 6 months * Pregnancy * A history of drug addiction or alcohol abuse within the past 12 months. Alcohol can be consumed in moderation. The consumption of alcohol should be within the routine pattern for the individual before the study. * A history of seizure disorder. * Allergy to propofol, soy beans, or eggs. * Prior history of difficult intubation. * Prior history of severe complications during conscious sedation. Study entry will be based on the investigator's judgment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A change in mean arterial pressure (MAP) of 20% or more from baseline | during upper endoscopy |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| ECG changes consistent with myocardial ischemia | during upper endoscopy |
| Decrease in respiratory rate - change of 20% or more from baseline | during upper endoscopy |
| Apneic episodes | during upper endoscopy |
| Episodes of bradycardia - pulse less than 50 | during upper endoscopy |
Countries
United States
Outcome results
None listed