NCT00782873|Completed
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Sponsor study identifier
observational
65
1 country
1
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2008
Actual (reported)Study Completion
September 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
August 2008
Actual (reported)September 2008
Actual (reported)October 29, 2008
Actual (reported)October 31, 2008
Actual (reported)A change in mean arterial pressure (MAP) of 20% or more from baseline
during upper endoscopy
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
BMI \> 35
The research subjects will be selected from a private practice.
Research Associates of New York
New York, New York, 10075, United States
Lawrence B Cohen, MD
Research Associates of New York
65 participants (actual enrollment reported by the registry).
First Submitted
October 29, 2008
First Posted
October 31, 2008
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Pharmacokinetic Properties of Lorcaserin in Obese or Overweight Elderly Subjects
Contact the study team to confirm eligibility.
Primary Completion
August 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Last Updated
October 31, 2008
Record last verified: 2008-10
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Source: ClinicalTrials.gov.
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