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Clinical Trials/NCT00559260
NCT00559260CompletedNot Applicable

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

Ethicon Endo-Surgery1 site in 1 country300 target enrollmentStarted: January 2003Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
300
Locations
1
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •(>=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.

Investigators

Sponsor
Ethicon Endo-Surgery
Sponsor Class
Industry

Study Sites (1)

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