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Completed

NCT Number: NCT00782873

Balanced Propofol Sedation During Upper Endoscopy in Morbidly 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.

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Associates of New York

New York, 10075, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: during upper endoscopy

Secondary outcomes

  1. Episodes of bradycardia - pulse less than 50

    Time frame: during upper endoscopy

  2. ECG changes consistent with myocardial ischemia

    Time frame: during upper endoscopy

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

    Time frame: during upper endoscopy

  4. 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

  5. Compare the level of sedation between the obese and non-obese cohorts

    Time frame: after all patients completed

  6. compare patient satisfaction with endoscopic sedation in obese and non-obese cohorts

    Time frame: after all patients completed

  7. Compare time to sedation in the obese and non-obese cohorts

    Time frame: after all patients completed

  8. Oxygen desaturation

    Time frame: during upper endoscopy

  9. Apneic episodes

    Time frame: during upper endoscopy

Sponsors and collaborators

Lead sponsor

Research Associates of New York, LLP

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Oct 31, 2008
Registry last updated
Oct 31, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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