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

NCT ID: NCT00559260

Last Updated: 2008-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sedation for Non-Emergent Upper and/or Lower Endoscopy

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Passive monitoring with pulse-oximetry, NIBP and ECG

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* (\>=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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon Endo-Surgery

INDUSTRY

Sponsor Role lead

Principal Investigators

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Philip Miner, MD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma Foundation for Digestive Research

Locations

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Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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CI-02-0004

Identifier Type: -

Identifier Source: org_study_id