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

Ethicon

Status: Completed

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

Treatments: Device: Passive monitoring with pulse-oximetry, NIBP and ECG

Study type: Observational

Funder types: Industry

Identifiers

NCT00559260

CI-02-0004

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.