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

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.

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Key information

Conditions

Sedation for Non-Emergent Upper and/or Lower Endoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oklahoma Foundation for Digestive Research

Oklahoma City, Oklahoma, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Passive monitoring with pulse-oximetry, NIBP and ECG

Device

Sponsors and collaborators

Lead sponsor

Ethicon Endo-Surgery

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
First posted: Nov 16, 2007
Registry last updated: Sep 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.