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

This study has been completed.

Sponsored by:	Ethicon Endo-Surgery
Information provided by:	Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:	NCT00559260

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

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

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

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

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

ClinicalTrials.gov processed this record on January 16, 2009