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Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography

NCT03114774 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2017-04-14

No results posted yet for this study

Summary

The bispectral index (BIS) monitoring is an EEG-based method that uses electroencephalogram analysis and a complex algorithm to generate a numerical scoring 0-100 (0 flat line EEG, 100, wide awake) BIS monitoring allows noninvasive, objective measurement of level of consciousness of a sedated patient. A limited number of studies have used measurements of BIS monitoring to assist endoscopic sedation.There are studies using BIS monitoring to make sedation easy for ERCP procedures. However, the studies evaluating use of BIS for gastrointestinal endoscopy show inconsistent results.

The objective of this study is to evaluate effects of sedation on the dosage of propofol by monitoring with BIS values, hemodynamics, recovery parameters, respiratory functions and endoscopist satisfaction based on the hypothesis that the investigators would reduce the risk for respiratory depression using minimal doses of propofol in order to achieve the desired level of sedation with BIS monitoring.

Conditions

  • Sedoanalgesia

Interventions

DEVICE

The bispectral index (BIS) monitoring

BEHAVIORAL

Ramsay Sedation Scale (RSS) Score monitoring

Sponsors & Collaborators

  • Istanbul Medeniyet University

    lead OTHER

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-15
Primary Completion
2017-05-01
Completion
2017-06-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03114774 on ClinicalTrials.gov