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

Completed

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

In brief

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.

Key facts

Study ID

NCT00559260

Run by

Ethicon Endo-Surgery

People needed

300

Starts

2003-01-01

Last updated by the study team

2008-09-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Oklahoma Foundation for Digestive Research — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.