Clinical trial NCT00782873: Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients
Official title: Balanced Propofol Sedation During Upper Endoscopy in Morbidly Obese Patients: Assessment of Cardiopulmonary Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: propofol
sedation
safety
obesity
Lead sponsor: Research Associates of New York, LLP
Sponsor class: OTHER
First posted: 2008-10-31
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research subjects will be selected from a private practice.

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.

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 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.

Primary outcomes:
measure: A change in mean arterial pressure (MAP) of 20% or more from baseline
timeFrame: during upper endoscopy
Secondary outcomes:
measure: Episodes of bradycardia - pulse less than 50
timeFrame: during upper endoscopy
measure: ECG changes consistent with myocardial ischemia
timeFrame: during upper endoscopy
measure: Decrease in respiratory rate - change of 20% or more from baseline
timeFrame: during upper endoscopy
measure: 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.
timeFrame: after all patients completed
measure: Compare the level of sedation between the obese and non-obese cohorts
timeFrame: after all patients completed
measure: compare patient satisfaction with endoscopic sedation in obese and non-obese cohorts
timeFrame: after all patients completed
measure: Compare time to sedation in the obese and non-obese cohorts
timeFrame: after all patients completed
measure: Oxygen desaturation
timeFrame: during upper endoscopy
measure: Apneic episodes
timeFrame: during upper endoscopy
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Associates of New York
state: New York
Study officials:
affiliation: Research Associates of New York
name: Lawrence B Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: