Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients

This study has been completed.
Sponsor:
Information provided by:
Research Associates of New York, LLP
ClinicalTrials.gov Identifier:
NCT00782873
First received: October 29, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  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

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

Resource links provided by NLM:


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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Research Associates of New York, LLP:
propofol
sedation
safety
obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on September 29, 2014