Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography

Istanbul Medeniyet University

Status: Unknown

Conditions: Sedoanalgesia

Treatments: Device: The bispectral index (BIS) monitoring; Behavioral: Ramsay Sedation Scale (RSS) Score monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT03114774

71306642-050.01.04-21/29

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 20-75 years old
2. ASA 1-2

Exclusion criteria

1. Emergency Operation
2. Those who had symptoms of neurological disease (TİA, syncope, dementia, etc.)
3. Patients that are allergic to drugs considered to use

Trial design

60 participants in 2 patient groups

grup 1

Description:

Ramsay Sedation Scale (RSS) Score monitoring

Treatment:

Behavioral: Ramsay Sedation Scale (RSS) Score monitoring

Grup 2

Description:

The bispectral index (BIS) monitoring

Treatment:

Device: The bispectral index (BIS) monitoring