Expired Study
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Oklahoma City, Oklahoma


Purpose:

This is a 300 subject prospective study to assess cardiorespiratory events associated with current practice sedation (150 subjects; opioid + benzodiazepine) versus anesthesia provider sedation (150 subjects; propofol) for upper and/or lower endoscopy.


Criteria:

Inclusion Criteria:adult - (>=18 years),ASA I-III, non-emergent upper and/or lower endoscopy Exclusion Criteria: - Emergent indications for upper and/or lower endoscopy (i.e., acute hemorrhage, cholangitis) - Baseline respiratory rate of < 6 breaths per minute - Baseline hypotension (systolic blood pressure < 90 mm Hg) - Baseline arterial oxygen saturation < 90% on room air - Baseline bradycardia: heart rate < 50 beats per minute - Baseline tachycardia: heart rate > 110 beats per minute - Allergy or inability to tolerate any of the sedatives or analgesics to be administered during the procedure - Inability to squeeze the Automated Responsiveness Test hand piece (last 50 subjects only) - Significant hearing impairment - Actively abusing alcohol, opioids, benzodiazapines or sedatives, or other drugs - Are considered tolerant to opioids, benzodiazapines and/or other sedatives through prescription.


NCT ID:

NCT00559260


Primary Contact:

Principal Investigator
Philip Miner, MD
Oklahoma Foundation for Digestive Research


Backup Contact:

N/A


Location Contact:

Oklahoma City, Oklahoma
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 17, 2017

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