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Clinical Trials/NCT03114774
NCT03114774
Unknown
Not Applicable

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

Istanbul Medeniyet University0 sites60 target enrollmentApril 15, 2017
ConditionsSedoanalgesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sedoanalgesia
Sponsor
Istanbul Medeniyet University
Enrollment
60
Primary Endpoint
Total dosage of propofol
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2017
End Date
June 1, 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Istanbul Medeniyet University
Responsible Party
Principal Investigator
Principal Investigator

Ferda Yilmaz Inal

Assistant Professor

Istanbul Medeniyet University

Eligibility Criteria

Inclusion Criteria

  • 20-75 years old

Exclusion Criteria

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

Outcomes

Primary Outcomes

Total dosage of propofol

Time Frame: 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)

Time Frame: 1-3 hours

During procedure

peripheral oxygen saturation (%)

Time Frame: 1-3 hours

During procedure

mean systolic-diastolic blood pressure(mmHg)

Time Frame: 1-3 hours

during procedure

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