Sedation Clinical Trial
— EndoBISsOfficial title:
Bispectral Index Monitoring as an Adjunct to Standard Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography
Verified date | May 2010 |
Source | Technische Universität München |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Indication for ERCP (Endoscopic Retrograde Cholangiopancreatography) with midazolam and propofol sedation Exclusion Criteria: - Missing informed consent - ASA V - Preexisting neurological deficit - Known pregnancy - Hypotension (RRsys<90mmHg), bradycardia (HR<50/min), hypoxia (SaO2<90%) |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum rechts der Isar der Technischen Universität München | Munich | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Technische Universität München | Medtronic - MITG |
Germany,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cardiopulmonary complications of sedation | 1-4 hours | Yes | |
Secondary | Efficacy of sedation | 1-4 hours | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03399019 -
Bispectral Index(BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia
|
N/A | |
Completed |
NCT03220880 -
Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
|
||
Recruiting |
NCT04820205 -
Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children
|
N/A | |
Recruiting |
NCT04549623 -
End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography
|
N/A | |
Recruiting |
NCT04822064 -
Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation
|
N/A | |
Completed |
NCT01001533 -
Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation
|
N/A | |
Completed |
NCT01527903 -
A Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation in the Intensive Care Unit
|
Phase 4 | |
Completed |
NCT00747721 -
Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU
|
Phase 1 | |
Completed |
NCT00158873 -
Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects
|
Phase 4 | |
Terminated |
NCT00205517 -
Sedation and Psychopharmacology in Critical Care
|
N/A | |
Recruiting |
NCT04096768 -
The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation
|
Phase 3 | |
Active, not recruiting |
NCT05082623 -
The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters
|
N/A | |
Suspended |
NCT03285165 -
Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT04788589 -
Sedation and Ventilator Weaning Protocol in PICU
|
N/A | |
Completed |
NCT03425474 -
Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
|
Phase 3 | |
Recruiting |
NCT06061159 -
The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction
|
Phase 4 | |
Completed |
NCT06449365 -
Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy
|
Phase 4 | |
Completed |
NCT02171910 -
Doxapram as an Additive to Propofol Sedation in Sedation for ERCP
|
Phase 4 | |
Completed |
NCT02211118 -
Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD
|
Phase 4 | |
Completed |
NCT01694745 -
EUROpean Pain Audit In Neonates
|
N/A |