Evaluation of Cardiorespiratory Events in Subjects Undergoing an Upper and/or Lower Endoscopy Under Current Sedation Practices

Completed

• Conditions: Sedation for Non-Emergent Upper and/or Lower Endoscopy

• Registration Number: NCT00559260
• Lead Sponsor: Ethicon Endo-Surgery

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-12
• Last Update Posted: 2008-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Oklahoma Foundation for Digestive Research; 🇺🇸 Oklahoma City, Oklahoma, United States