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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:
ClinicalTrials.gov Identifier:
NCT00559260
First Posted: November 16, 2007
Last Update Posted: September 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ethicon Endo-Surgery
  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:


Further study details as provided by Ethicon Endo-Surgery:

Estimated Enrollment: 300
Study Start Date: January 2003
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

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