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

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ClinicalTrials.gov Identifier: NCT00559260
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : September 15, 2008
Sponsor:
Information provided by:
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.

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

Study Type : Observational
Enrollment : 300 participants
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
Study Start Date : January 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources





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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00559260     History of Changes
Other Study ID Numbers: CI-02-0004
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: September 15, 2008
Last Verified: September 2008