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
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oklahoma Foundation for Digestive Research
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma Foundation for Digestive Research🇺🇸Oklahoma City, Oklahoma, United States