CompletedNCT00782873Updated Oct 31, 2008

Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients

An observational study in Obesity, sponsored by Research Associates of New York, LLP. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-10-31.

Sponsored by Research Associates of New York, LLP · Observational

Study type: Observational
Model: Case-control
Time perspective: Prospective
Enrollment: 65
Ages: 18 Years to 85 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Obesity

Browse trials for

Obesity 6,296

Keywords

propofol
sedation
safety
obesity

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 65 is below the median of 135 across 1,283 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Research Associates of New York, LLP is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

The research subjects will be selected from a private practice.

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

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.

Study design

Observational model: Case-control
Time perspective: Prospective
Enrollment: 65 participants (actual)

Groups and cohorts

obese subjects
BMI \> 35

What researchers measure

Primary outcomes

A change in mean arterial pressure (MAP) of 20% or more from baseline
Time frame: during upper endoscopy

Secondary outcomes

Episodes of bradycardia - pulse less than 50
Time frame: during upper endoscopy
ECG changes consistent with myocardial ischemia
Time frame: during upper endoscopy
Decrease in respiratory rate - change of 20% or more from baseline
Time frame: 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.
Time frame: after all patients completed
Compare the level of sedation between the obese and non-obese cohorts
Time frame: after all patients completed
compare patient satisfaction with endoscopic sedation in obese and non-obese cohorts
Time frame: after all patients completed
Compare time to sedation in the obese and non-obese cohorts
Time frame: after all patients completed
Oxygen desaturation
Time frame: during upper endoscopy
Apneic episodes
Time frame: during upper endoscopy

Study locations

1 site

Research Associates of New York
New York, New York 10075, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 31, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00782873
Lead sponsor: Research Associates of New York, LLP
First posted: Oct 31, 2008
Start date: Mar 2008
Primary completion: Aug 2008
Completion: Sep 2008
Last update: Oct 31, 2008

Study contacts

Lawrence B Cohen, MD

principal investigator · Research Associates of New York

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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