Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography

Sedoanalgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03114774
• Other study ID #: 71306642-050.01.04-21/29
• Status: Not yet recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: April 10, 2017
• Start date: April 15, 2017
• Est. completion date: June 1, 2017

Study information

• Verified date: March 2017
• Source: Istanbul Medeniyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2017
• Est. primary completion date: May 1, 2017
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 20-75 years old

2. ASA 1-2

Exclusion Criteria:

1. Emergency Operation

2. Those who had symptoms of neurological disease (TIA, syncope, dementia, etc.)

3. Patients that are allergic to drugs considered to use

Related Conditions & MeSH terms

• Sedoanalgesia

Intervention

Device:
• The bispectral index (BIS) monitoring

Behavioral:
• Ramsay Sedation Scale (RSS) Score monitoring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medeniyet University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The heart rate (HR)(n/dk)	During procedure	1-3 hours
Primary	mean systolic-diastolic blood pressure(mmHg)	during procedure	1-3 hours
Primary	peripheral oxygen saturation (%)	During procedure	1-3 hours