Procedural Sedation Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled 9-period Crossover, Dose-Escalation Study on the Safety, Bioavailability and Pharmacodynamics of Remimazolam Administered Intranasally as Powder and as Solution in Healthy Subjects
A prospective dose escalation, nine period cross-over trial assessing the safety, pharmacokinetics, bioavailability and pharmacodynamics of escalating doses of Remimazolam when administered intranasally as powder and solution in healthy subjects and compared to an intravenous control
The design will be a randomized, double-blind, comparative, placebo- and active-controlled nine-period crossover study in healthy male volunteers. Subjects will be randomized and will receive each of the 9 treatments which will be separated by a minimum of 48 hours.The first treatment arm will always be the intravenous remimazolam. Eligible subjects will then be randomized to treatment sequence prior to study drug administration in treatment period 2. Each subject will participate in the study for up to 51 days, from Screening until Follow-up. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03692390 -
Virtual Reality vs. Standard-of-Care for Comfort Before and After Sedation in the Emergency Department
|
N/A | |
| Completed |
NCT02145169 -
Inhaled Nitrous Oxide for the Prevention of Emergence Reaction During Ketamine Administration in Adults, a Pilot Study
|
N/A | |
| Recruiting |
NCT05595798 -
EEG Spectral Pattern of Deep Sedation-induced Airway Adverse Effects
|
||
| Completed |
NCT01260662 -
Randomized Clinical Trial of Propofol, 1:1 and 4:1 Combination of Propofol and Ketamine for Procedural Sedation
|
Phase 4 | |
| Completed |
NCT00784498 -
Procedural Sedation Using Propofol Versus Midazolam/Ketamine in the Adult Emergency Department
|
Phase 4 | |
| Completed |
NCT00327392 -
A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures.
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04873596 -
Dexmedetomidine and Midazolam Nebulization as Sedation During Cesarean Delivery in Pre-eclampsia
|
Phase 2 | |
| Recruiting |
NCT06414395 -
The Effects of Different Loading Doses of Dexmedetomidine on The Bispectral Index-Guided Propofol Sedation in Patients Undergoing Advanced Upper Gastrointestinal Endoscopic Procedures: A Randomized Control Study
|
Phase 4 | |
| Recruiting |
NCT03860831 -
Intranasal Ketamine and Midazolam Mixture for Procedural Sedation in Children With Mental Disabilities:
|
Phase 1 | |
| Completed |
NCT00869440 -
Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy
|
Phase 2 | |
| Not yet recruiting |
NCT05757622 -
Electroencephalogram Based Real-Time Sedation Level Prediction
|
||
| Completed |
NCT03799783 -
The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders
|
Phase 2 | |
| Completed |
NCT02180737 -
Dexmedetomidine for Sedation During Radiological Interventional Procedures
|
Phase 4 | |
| Not yet recruiting |
NCT01227174 -
Safety and Efficacy of Propofol Only Sedation in Oral and Maxillofacial Surgery
|
Phase 4 | |
| Recruiting |
NCT03499886 -
Low-Dose Intravenous Ketamine Bolus Versus Conventional Technique
|
Phase 2/Phase 3 | |
| Completed |
NCT03747432 -
Comparison of Procedural Sedation With Propofol and Dexmedetomidine During Transcatheter Aortic Valve Implantation
|
Phase 4 | |
| Recruiting |
NCT06203522 -
Factors Associated With Successful Completion of MRI in Children Undergoing a Vigil Sedation With Dexmedetomidin
|
||
| Withdrawn |
NCT05783492 -
INK Feasibility Study
|
Phase 3 | |
| Recruiting |
NCT04686448 -
Ketofol Versus Fenofol as Procedural Sedation for Carpal Tunnel Release
|
Phase 1/Phase 2 | |
| Completed |
NCT02955732 -
Pharmacological Characteristics of Intranasally Given Dexmedetomidine in Paediatric Patients
|
Phase 4 |