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Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients

NCT ID: NCT00782873

Last Updated: 2008-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-09-30

Brief Summary

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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.

The investigators aim to test the hypothesis that it is safe to use balanced-propofol, gastroenterologist-administered sedation in obese patients.

Detailed Description

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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.

Conditions

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Obesity

Keywords

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propofol sedation safety obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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obese subjects

BMI \> 35

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Research Associates of New York, LLP

OTHER

Sponsor Role lead

Responsible Party

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Research Associates Of New York

Principal Investigators

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Lawrence B Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Research Associates of New York

Locations

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Research Associates of New York

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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424-02-08

Identifier Type: -

Identifier Source: org_study_id