Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients - Full Text View

Sponsored by:	Research Associates of New York, LLP
Information provided by:	Research Associates of New York, LLP
ClinicalTrials.gov Identifier:	NCT00782873

Purpose

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.

Condition
Obesity

MedlinePlus related topics: Endoscopy Obesity

Drug Information available for: Propofol

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients: Assessment of Cardiopulmonary Parameters

Further study details as provided by Research Associates of New York, LLP:

Primary Outcome Measures:

A change in mean arterial pressure (MAP) of 20% or more from baseline [ Time Frame: during upper endoscopy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Episodes of bradycardia - pulse less than 50 [ Time Frame: during upper endoscopy ] [ Designated as safety issue: Yes ]
ECG changes consistent with myocardial ischemia [ Time Frame: during upper endoscopy ] [ Designated as safety issue: Yes ]
Decrease in respiratory rate - change of 20% or more from baseline [ Time Frame: during upper endoscopy ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Compare the level of sedation between the obese and non-obese cohorts [ Time Frame: after all patients completed ] [ Designated as safety issue: No ]
compare patient satisfaction with endoscopic sedation in obese and non-obese cohorts [ Time Frame: after all patients completed ] [ Designated as safety issue: No ]
Compare time to sedation in the obese and non-obese cohorts [ Time Frame: after all patients completed ] [ Designated as safety issue: No ]
Oxygen desaturation [ Time Frame: during upper endoscopy ] [ Designated as safety issue: Yes ]
Apneic episodes [ Time Frame: during upper endoscopy ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	65
Study Start Date:	March 2008
Study Completion Date:	September 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
obese subjects BMI > 35

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

The research subjects will be selected from a private practice.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00782873

Locations

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

Sponsors and Collaborators

Research Associates of New York, LLP

Investigators

Principal Investigator:

Lawrence B Cohen, MD

Research Associates of New York

More Information

No publications provided

Responsible Party:	Research Associates Of New York ( Lawrence B. Cohen, MD )
Study ID Numbers:	424-02-08
Study First Received:	October 29, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00782873 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Research Associates of New York, LLP:

propofol
sedation
safety
obesity

Study placed in the following topic categories:

Anesthetics, Intravenous
Body Weight
Signs and Symptoms
Obesity
Anesthetics, General
Hypnotics and Sedatives

Central Nervous System Depressants
Anesthetics
Nutrition Disorders
Overweight
Overnutrition
Propofol

Additional relevant MeSH terms:

Anesthetics, Intravenous
Obesity
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Overweight
Pharmacologic Actions
Body Weight

Signs and Symptoms
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Nutrition Disorders
Overnutrition
Propofol
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009