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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00559260

Enrollment

300

Registered

2007-11-16

Start date

2003-01-31

Completion date

Unknown

Last updated

2008-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sedation for Non-Emergent Upper and/or Lower Endoscopy

Brief summary

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.

Interventions

DEVICEPassive monitoring with pulse-oximetry, NIBP and ECG

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026