Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients

Research Associates of New York, LLP

Status: Completed

Conditions: Obesity

Study type: Observational

Funder types: Other

Identifiers

NCT00782873

424-02-08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

65 participants in 1 patient group

obese subjects

Description:

BMI \> 35