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

September 12, 2008 updated by: Ethicon Endo-Surgery

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Oklahoma Foundation for Digestive Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ethicon Endo-Surgery

Investigators

  • Principal Investigator: Philip Miner, MD, Oklahoma Foundation for Digestive Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Estimate)

September 15, 2008

Last Update Submitted That Met QC Criteria

September 12, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • CI-02-0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe