SedoanalgesiaNCT03114774
Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography
An observational study of Sedoanalgesia, run by Istanbul Medeniyet University.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Sedoanalgesia
- What is being tested?
- The bispectral index (BIS) monitoring and Ramsay Sedation Scale (RSS) Score monitoring
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2017to 1 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Adult, Older adult
Study population: patients in ASA 1-2 category scheduled for sedation and ERCP
Who may be able to join
- 20-75 years old
- ASA 1-2
Who cannot join
- Emergency Operation
- Those who had symptoms of neurological disease (TİA, syncope, dementia, etc.)
- Patients that are allergic to drugs considered to use
About this study
Official title: Evaluation of Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography Received Sedoanalgesia
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.
- Conditions
- Sedoanalgesia
- Being tested
- The bispectral index (BIS) monitoring, Ramsay Sedation Scale (RSS) Score monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The bispectral index (BIS) monitoringDevice
Ramsay Sedation Scale (RSS) Score monitoringBehavioural
| Study group | Role | What they receive |
|---|---|---|
| grup 1 | Ramsay Sedation Scale (RSS) Score monitoring Receives: Behavioral: Ramsay Sedation Scale (RSS) Score monitoring | |
| Grup 2 | The bispectral index (BIS) monitoring Receives: Device: The bispectral index (BIS) monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-3 hours
The heart rate (HR)(n/dk)
During procedure
Measured: 1-3 hours
mean systolic-diastolic blood pressure(mmHg)
during procedure
Measured: 1-3 hours
peripheral oxygen saturation (%)
During procedure
Measured: 1-3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start15 Apr 2017 (estimated)
- Primary completion1 May 2017 (estimated)
- Study completion1 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedoanalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferda Yilmaz Inal, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114774
- Sponsor's protocol ID
- 71306642-050.01.04-21/29
- Status last verified
- Mar 2017
- First submitted
- 20 Mar 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectivity of Bispectral Index Monitoring in Cases of Endoscopic Retrograde Cholangiopancreatography Received Sedoanalgesia
- ClinicalTrials.gov ID
- NCT03114774
- Acronym / sponsor ID
- 71306642-050.01.04-21/29
- Conditions
- Sedoanalgesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 Apr 2017 (estimated)
- Primary completion
- 1 May 2017 (estimated)
- Study completion
- 1 Jun 2017 (estimated)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| grup 1 | – | Behavioral: Ramsay Sedation Scale (RSS) Score monitoringRamsay Sedation Scale (RSS) Score monitoring |
| Grup 2 | – | Device: The bispectral index (BIS) monitoringThe bispectral index (BIS) monitoring |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients in ASA 1-2 category scheduled for sedation and ERCP
Key inclusion criteria (2 listed)
- 20-75 years old
- ASA 1-2
Key exclusion criteria (3 listed)
- Emergency Operation
- Those who had symptoms of neurological disease (TİA, syncope, dementia, etc.)
- Patients that are allergic to drugs considered to use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The bispectral index (BIS) monitoring | Device | Grup 2 |
| Ramsay Sedation Scale (RSS) Score monitoring | Behavioural | grup 1 |
Primary outcome
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
mean systolic-diastolic blood pressure(mmHg)
Time frame: 1-3 hours
during procedure
peripheral oxygen saturation (%)
Time frame: 1-3 hours
During procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sedoanalgesia, run by Istanbul Medeniyet University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total dosage of propofol (time frame: 1-3 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.