Status:
COMPLETED
Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients
Lead Sponsor:
Research Associates of New York, LLP
Conditions:
Obesity
Eligibility:
All Genders
18-85 years
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 t...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00782873
Start Date
March 1 2008
End Date
September 1 2008
Last Update
October 31 2008
Active Locations (1)
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1
Research Associates of New York
New York, New York, United States, 10075