Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography

• Conditions: Sedoanalgesia
• Interventions: Behavioral: Ramsay Sedation Scale (RSS) Score monitoring; Device: The bispectral index (BIS) monitoring

• Registration Number: NCT03114774
• Lead Sponsor: Istanbul Medeniyet University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-03
• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-04-10
• Last Update Submitted: 2017-04-10
• Study First Posted: 2017-04-14
• Last Update Posted: 2017-04-14
• Study Start: 2017-04-15
• Primary Completion: 2017-05-01
• Study Completion: 2017-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
grup 1	Ramsay Sedation Scale (RSS) Score monitoring	Ramsay Sedation Scale (RSS) Score monitoring
Grup 2	The bispectral index (BIS) monitoring	The bispectral index (BIS) monitoring

Primary Outcome Measures

Name	Time	Method
Total dosage of propofol	1-3 hours	initial dose 1 mg.kg-1 of propofol, maintenance dose: infusion of 4 mg/kg/h . In case of insufficient sedation, additional dose of 0.1 mg/kg propofol (IV) by monitoring with BIS values 65-75 during procedure
The heart rate (HR)(n/dk)	1-3 hours	During procedure
peripheral oxygen saturation (%)	1-3 hours	During procedure
mean systolic-diastolic blood pressure(mmHg)	1-3 hours	during procedure