Gastrointestinal EndoscopyEndoBISsNCT00952458
Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography
A study testing BIS monitoring in people with Gastrointestinal Endoscopy and Sedation, run by Technical University of Munich at 1 site in Germany.
Trial summary
This randomized study investigates the benefits of an additional Bispectral Index monitoring of depth of sedation during endoscopic retrograde cholangiopancreaticography. A bispectral index (BIS) monitor is a neurophysiological monitoring device which continually analyses a patient's electroencephalograms during… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Endoscopy, Sedation
- What is being tested?
- BIS monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2009to May 2010
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for ERCP (Endoscopic Retrograde Cholangiopancreatography) with midazolam and propofol sedation
Who cannot join
- Missing informed consent
- ASA V
- Preexisting neurological deficit
- Known pregnancy
- Hypotension (RRsys<90mmHg), bradycardia (HR<50/min), hypoxia (SaO2<90%)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, 81675
About this study
Official title: Bispectral Index Monitoring as an Adjunct to Standard Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography
This randomized study investigates the benefits of an additional Bispectral Index monitoring of depth of sedation during endoscopic retrograde cholangiopancreaticography. A bispectral index (BIS) monitor is a neurophysiological monitoring device which continually analyses a patient's electroencephalograms during general anaesthesia to assess the level of consciousness during anaesthesia.
- Conditions
- Gastrointestinal Endoscopy, Sedation
- Being tested
- BIS monitoring
- Keywords
- Safety, Midazolam and propofol sedation, ERCP, Bispectral Index monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS monitoringDevice
Neuromonitoring of depth of sedation with Bispectral Index
| Study group | Role | What they receive |
|---|---|---|
| BIS monitoring | Experimental | Dosing of sedatives with BIS monitoring Receives: Device: BIS monitoring |
| Standard monitoring | No intervention | Dosing of sedatives without BIS monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiopulmonary complications of sedation
Measured: 1-4 hours
Secondary outcomes (1)
Efficacy of sedation
Measured: 1-4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal EndoscopyStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Investigators
- Stefan von Delius, MD, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952458
- Sponsor's protocol ID
- 2094/08
- Acronym
- EndoBISs
- Status last verified
- May 2010
- First submitted
- 2 Aug 2009
- Last updated
- 24 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
von Delius S, Thies P, Rieder T, Wagenpfeil S, Herberich E, Karagianni A, Frimberger E, Meining A, Ludwig L, Ebert MP, Schulte-Frohlinde E, Neu B, Prinz C, Schmid RM, Huber W. Auditory evoked potentials compared with bispectral index for monitoring of midazolam and propofol sedation during colonoscopy. Am J Gastroenterol. 2009 Feb;104(2):318-25. doi: 10.1038/ajg.2008.73. Epub 2009 Jan 20.
PubMed 19190608
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Index Monitoring as an Adjunct to Standard Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography
- ClinicalTrials.gov ID
- NCT00952458
- Acronym / sponsor ID
- EndoBISs / 2094/08
- Conditions
- Gastrointestinal Endoscopy, Sedation
- Keywords
- Safety, Midazolam and propofol sedation, ERCP, Bispectral Index monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Jul 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 6 Aug 2009 (estimated)
- 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.
This randomized study investigates the benefits of an additional Bispectral Index monitoring of depth of sedation during endoscopic retrograde cholangiopancreaticography. A bispectral index (BIS) monitor is a neurophysiological monitoring device which continually analyses a patient's electroencephalograms during general anaesthesia to assess the level of consciousness during anaesthesia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIS monitoring | Experimental | Device: BIS monitoringDosing of sedatives with BIS monitoring |
| Standard monitoring | No intervention | –Dosing of sedatives without BIS monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication for ERCP (Endoscopic Retrograde Cholangiopancreatography) with midazolam and propofol sedation
Key exclusion criteria (5 listed)
- Missing informed consent
- ASA V
- Preexisting neurological deficit
- Known pregnancy
- Hypotension (RRsys<90mmHg), bradycardia (HR<50/min), hypoxia (SaO2<90%)
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 |
|---|---|---|
| BIS monitoringNeuromonitoring of depth of sedation with Bispectral Index | Device | BIS monitoring |
Primary outcome
Cardiopulmonary complications of sedation
Time frame: 1-4 hours
1 secondary outcome
Efficacy of sedation
Time frame: 1-4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2012.
- Background: PubMed 19190608von Delius S, Thies P, Rieder T, Wagenpfeil S, Herberich E, Karagianni A, Frimberger E, Meining A, Ludwig L, Ebert MP, Schulte-Frohlinde E, Neu B, Prinz C, Schmid RM, Huber W. Auditory evoked potentials compared with bispectral index for monitoring of midazolam and propofol sedation during colonoscopy. Am J Gastroenterol. 2009 Feb;104(2):318-25. doi: 10.1038/ajg.2008.73. Epub 2009 Jan 20.
Related trials for Gastrointestinal Endoscopy
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingObservational study
Outcomes of Knife-Assisted Full-Thickness Resection for Rectal Lesions: A Multicenter Study
Colorectal Cancer
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
Recruiting
Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery
Breast Cancer
Recruiting
Epinephrine 1:100,000 Versus 1:500,000 During Gastric Endoscopic Submucosal Dissection
Gastric Neoplasms, Gastric Dysplasia
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.
Stefan von Delius, MD principal investigator
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIS monitoring in people with Gastrointestinal Endoscopy and Sedation, run by Technical University of Munich at 1 site in Germany.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 24 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiopulmonary complications of sedation (time frame: 1-4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00952458, which also lists 1 linked publication.
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 24 Aug 2012.