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

This study has been completed.
Sponsor:
Information provided by:
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00559260
First received: November 15, 2007
Last updated: September 12, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention
Sedation for Non-Emergent Upper and/or Lower Endoscopy
 Device: Passive monitoring with pulse-oximetry, NIBP and ECG

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Cardiorespiratory Events in Subjects Undergoing an Upper and/or Lower Endoscopy Under Current Sedation Practices While Being Passively Monitored

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Ethicon Endo-Surgery:

Estimated Enrollment: 300
Study Start Date: January 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559260

Locations
United States, Oklahoma
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Sponsors and Collaborators
Ethicon Endo-Surgery
Investigators
Principal Investigator: Philip Miner, MD Oklahoma Foundation for Digestive Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00559260     History of Changes
Other Study ID Numbers: CI-02-0004
Study First Received: November 15, 2007
Last Updated: September 12, 2008
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013