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

October 29, 2008
October 29, 2008
March 2008
August 2008   (final data collection date for primary outcome measure)
A change in mean arterial pressure (MAP) of 20% or more from baseline [ Time Frame: during upper endoscopy ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

The research subjects will be selected from a private practice.

Obesity
Not Provided
obese subjects
BMI > 35
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
September 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00782873
424-02-08
No
Lawrence B. Cohen, MD, Research Associates Of New York
Research Associates of New York, LLP
Not Provided
Principal Investigator: Lawrence B Cohen, MD Research Associates of New York
Research Associates of New York, LLP
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP