NCT03114774

Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography

Evaluation of Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography Received Sedoanalgesia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Istanbul Medeniyet University · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: —

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

Type	Name	Description
DEVICE	The bispectral index (BIS) monitoring
BEHAVIORAL	Ramsay Sedation Scale (RSS) Score monitoring

Timeline

• Start date: 2017-04-15
• Primary completion: 2017-05-01
• Completion: 2017-06-01
• First posted: 2017-04-14
• Last updated: 2017-04-14