Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients

Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients: Assessment of Cardiopulmonary Parameters

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.

Study Overview

• Status: Completed
• Conditions: Obesity

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.

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The research subjects will be selected from a private practice.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
obese subjects; BMI > 35

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
compare patient satisfaction with endoscopic sedation in obese and non-obese cohorts	after all patients completed
Compare time to sedation in the obese and non-obese cohorts	after all patients completed
Oxygen desaturation	during upper endoscopy
Apneic episodes	during upper endoscopy

Collaborators and Investigators

• Sponsor: Research Associates of New York, LLP
• Investigators: Principal Investigator: Lawrence B Cohen, MD, Research Associates of New York

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: October 29, 2008
• First Submitted That Met QC Criteria: October 29, 2008
• First Posted (Estimate): October 31, 2008

Study Record Updates

• Last Update Posted (Estimate): October 31, 2008
• Last Update Submitted That Met QC Criteria: October 29, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: safety; obesity; sedation; propofol
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 424-02-08