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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03114774

Enrollment

Registered

2017-04-14

Start date

2017-04-15

Completion date

2017-06-01

Last updated

2017-04-14

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

Conditions

Sedoanalgesia

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.

Interventions

DEVICEThe bispectral index (BIS) monitoring

BEHAVIORALRamsay Sedation Scale (RSS) Score monitoring

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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
mean systolic-diastolic blood pressure(mmHg)	1-3 hours	during procedure
peripheral oxygen saturation (%)	1-3 hours	During procedure

Outcome results

None listed

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