Clinical trials: Sedation;
Gastroscopic and Colonoscopic Sedation
A Non-interventional Study of Remazolam Methyl Benzene Sulfonic Acid for Injection in Real-world Clinical Practice
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 2000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all…
- Trial name
- NCT05254366
- Testing
- Remimazolam Tosilate for Injection
- Where
- 19 sites in China
- Volunteers
- 2,022 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy
Neonatal Neurological Observation With Video AI
NeoNOVA is a multi-site, prospective, single-arm, silent observational study to determine: among (Population) infants admitted to newborn services during their inpatient hospital stay, whether (Intervention) continuous bedside…
- Conditions
- Neonatal Encephalopathy, Hypoxic-Ischemic Encephalopathy, Sedation, Sleep
- Trial name
- NeoNOVA (NCT07628829)
- Testing
- Continuous bedside video monitoring with AI anatomic landmark tracking for neurologic monitoring
- Where
- 2 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Artemis AI Labs
General Anesthesia and Bronchoscopy Sedation
A Non-intervention Fiberoptic Bronchoscopy Study of Remazolam Toluene Sulfonate for Injection Under General Anesthesia and Fiberoptic Bronchoscopy
This is a non-interventional study of remazolam toluenesulfonate (rebenin ®) for injection in Chinese patients. A total of 1000 patients were enrolled in this study based on the preliminary safety assessment of rebenin ®, and all…
- Trial name
- NCT05549791
- Testing
- Remimazolam Tosilate for Injection
- Where
- China
- Volunteers
- 1,285 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Preoperative Sedation of Adults
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Pharmacokinetic Profile of Single and Multiple Dose Escalation Topical Dermal Administration of SHR0302 Alkali Gel in Healthy Subjects
This study is divided into two parts, the first part is a single-dose dose escalation trial (SAD) in healthy subjects; The second part is a multiple-dose dose escalation trial (MAD) in healthy subjects.
- Trial name
- NCT07098117
- Testing
- SHR0302 Base Gel
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Airway Obstruction, Sedation Complication
Medical Device for Airway Patency During Sedation
OVERALL SYNOPSIS PART A: Systematic evaluation in spontaneously breathing healthy volunteer study participants of cumulative duration of manual measures for airway patency and for mask ventilation with airway device prototype…
- Conditions
- Airway Obstruction, Sedation Complication, Perioperative Complication
- Trial name
- STAIRWAY-2 (NCT06270212)
- Testing
- STAIRWAY, NO DEVICE
- Where
- Sweden
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Stairway Medical AB
Airway Obstruction, Sedation Complication
Evaluation of Medical Device for Airway Patency During Sedation (SW01-2022)
The goal of this four-part preclinical [I-II] and clinical [III-IV] trial is to compare, with randomised crossover study design [I-IV], a new medical airway device with standard procedure (biteblock or no device) for upper airway…
- Conditions
- Airway Obstruction, Sedation Complication, Safety Issues, Patient Satisfaction
- Trial name
- NCT05708651
- Testing
- Investigational device [I-IV], Comparator [I-IV]
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Stairway Medical AB
Digital Sedation
Healthy Volunteer Undergoing Painful Stimuli With and Without Hypnosis and Virtual Reality
The main purposes of this study are as follows: Compare the effect of painful stimuli with and without Hypnosis and Virtual Reality (HVR) on healthy volunteers.
- Trial name
- SMARTHY (NCT04107558)
- Testing
- Virtual Reality
- Where
- Belgium
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Oncomfort
Anesthesia, Sedation
A Study Evaluating the Mass Balance of Micro-dose[14C]HSK3486 Emulsion Injection in Healthy Adults
This study is designed to evaluate the mass balance in healthy Chinese male subjects after receiving a single dose of intravenous [14C]HSK3486, so as to assess the overall pharmacokinetics and safety of HSK3486 in humans and…
- Trial name
- NCT03751969
- Testing
- HSK3486
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Procedural Sedation
Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine
A Pivotal Phase 1, Randomized, Single-Dose, 4-Period, Crossover Relative Bioavailability Study of MELT-100, IV Midazolam, and IV Ketamine under Fasted Conditions in Healthy Volunteers
- Trial name
- NCT04767035
- Testing
- midazolam / ketamine sublingual tablet
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Melt Pharmaceuticals
Anesthesia, Sedation
A Study Evaluating Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of HSK3486 Single Bolus Dose Followed With a 30 Minute Constant Infusion in Healthy Male Subjects
This study was a single center, open-label, single dose escalation study in healthy male subjects to investigate a bolus dose followed by a 30 minute constant infusion of HSK3486 over two cohorts.
- Trial name
- NCT04029766
- Testing
- HSK3486
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Anesthesia, Sedation
A Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Voriconazole Tablets
This is a single-center, open-label, randomized, two-stage, two-way crossover study evaluating the effect of voriconazole on the PK, PD, and safety of HSK3486 in healthy subjects.
- Trial name
- NCT04145583
- Testing
- HSK3486, voriconazole +HSK3486
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Anesthesia, Sedation
A Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.
his single-center, open-label, uncontrolled, and dose-escalation study evaluated the safety, tolerability, and pharmacokinetics/pharmacodynamics of single IV dose of HSK3486 injectable emulsion in healthy subjects.
- Trial name
- NCT03773835
- Testing
- HSK3486
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Anesthesia, Sedation
A Study Evaluating the Safety and Pharmacokinetics/Pharmacodynamics of HSK3486
This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose after an initial dose and IV…
- Trial name
- NCT03745625
- Testing
- HSK3486, Propofol
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Anesthesia, Sedation
A Study Evaluating the Mass Balance of [14C]HSK3486 Emulsion Injection in Healthy Adults.
This study is designed to evaluate the mass balance and biotransformation pathways of HSK3486 in healthy Chinese male subjects administered with a single intravenous dose of [14C]HSK3486, so as to characterize the drug's general…
- Trial name
- NCT03751956
- Testing
- HSK3486
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Anesthesia, Sedation
A Study Evaluating Drug-Drug Interaction (DDI) Between HSK3486 Injectable Emulsion and Rifampin Capsules
This is a Phase I, single-center, open-label, randomized,two-way crossover, propofol-controlled, two-stage study evaluating the safety and pharmacokinetics/pharmacodynamics of IV maintenance dose and IV single loade dose plus…
- Trial name
- NCT03758469
- Testing
- HSK3486, rifampin , HSK3486
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
General Anesthetic, Sedation
A Study Evaluating Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 and Etomidate for Induction of Anesthesia in Healthy Male Subjects
This study is designed as an open label, single dose combination of HSK3486 and etomidate in healthy adult male subjects. The study will evaluate the anesthetic/sedation effect of the combination of the 2 drugs and the safety…
- Trial name
- NCT04054063
- Testing
- HSK3486+ etomidate
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Anesthesia, Sedation
A Study Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Subjects.
This is the first clinical trial of HSK3486 and will be conducted in healthy volunteers to determine the safety, tolerability (including pain on injection), and PK(only to be assessed for subjects who are randomized to HSK3486 in…
- Trial name
- NCT04033939
- Testing
- HSK3486, Propofol
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Procedural Sedation
A Trial of Intranasal Remimazolam Pharmacokinetics, Pharmacodynamics, Safety and Bioavailability
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…
- Trial name
- NCT03329014
- Testing
- Remimazolam
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Paion UK Ltd.
Sedation
Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects
The aim of this study is to investigate the safety, pharmacokinetics, pharmacodynamics of intranasal dexmedetomidine, and comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy…
- Trial name
- NCT03293277
- Testing
- Intranasal Dexmedetomidine, Intravenous Dexmedetomidine
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Conscious Sedation
Sedasys Post Approval Study Users Response to System Alarms
The purpose of this study is to evaluate the users' responses to the SEDASYS® System alarms during esophagogastroduodenoscopy (EGD) or colonoscopy.
- Trial name
- NCT02573818
- Testing
- SEDASYS System
- Where
- United States
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Ethicon Endo-Surgery