Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients

NCT00782873 | Completed

• 1 other identifier: 424-02-08
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

propofol; sedation; safety; obesity

Outcome Measures

Primary Outcomes (1)

• A change in mean arterial pressure (MAP) of 20% or more from baseline

  during upper endoscopy

Secondary Outcomes (9)

• Episodes of bradycardia - pulse less than 50

  during upper endoscopy

• ECG changes consistent with myocardial ischemia

  during upper endoscopy

• Decrease in respiratory rate - change of 20% or more from baseline

  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.

  after all patients completed

• Compare the level of sedation between the obese and non-obese cohorts

  after all patients completed

Study Arms (1)

obese subjects

BMI \> 35

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The research subjects will be selected from a private practice.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Associates of New York, LLP: lead

Study Sites (1)

Research Associates of New York

New York, New York, 10075, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lawrence B Cohen, MD

  Research Associates of New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: March 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 31, 2008

Record last verified: 2008-10

Locations

US (1)