Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients
Completed
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT00782873
- Run by
- Research Associates of New York, LLP
- People needed
- 65
- Starts
- 2008-03-01
- Expected to finish
- 2008-09-01
- Last updated by the study team
- 2008-10-31
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Research Associates of New York — New York, New York, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.