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
1 other identifier
observational
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2017
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 14, 2017
CompletedStudy Start
First participant enrolled
April 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedApril 14, 2017
March 1, 2017
16 days
March 20, 2017
April 10, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Total dosage of propofol
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
1-3 hours
The heart rate (HR)(n/dk)
During procedure
1-3 hours
mean systolic-diastolic blood pressure(mmHg)
during procedure
1-3 hours
peripheral oxygen saturation (%)
During procedure
1-3 hours
Study Arms (2)
grup 1
Ramsay Sedation Scale (RSS) Score monitoring
Grup 2
The bispectral index (BIS) monitoring
Interventions
Eligibility Criteria
patients in ASA 1-2 category scheduled for sedation and ERCP
You may qualify if:
- years old
- ASA 1-2
You may not qualify if:
- Emergency Operation
- Those who had symptoms of neurological disease (TİA, syncope, dementia, etc.)
- Patients that are allergic to drugs considered to use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 20, 2017
First Posted
April 14, 2017
Study Start
April 15, 2017
Primary Completion
May 1, 2017
Study Completion
June 1, 2017
Last Updated
April 14, 2017
Record last verified: 2017-03