Clinical trials: Sedation;
Sedation in the ICU
A Study of Remimazolam Tosilate for Sedation in the ICU
The purpose of this study is to explore the optimal dose regimen of Remimazolam Tosilate for Injection for sedation in the ICU, as well as preliminarily evaluate the efficacy and safety of Remimazolam Tosilate for Injection for…
- Trial name
- NCT05152303
- Testing
- Remimazolam Tosilate
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Gastrointestinal Endoscopy, Sedation
Sedation Of Adult Patients Undergoing Gastrointestinal Endoscopy: A Network Meta-analysis
The objective of this study is to compare the efficacy and safety of dexmedetomidine with other sedatives in sedation during endoscopy by analyzing the most recently published interventional trials and observational studies.
- Conditions
- Gastrointestinal Endoscopy, Sedation, Dexmedetomidine
- Trial name
- NCT03632330
- Testing
- Dexmedetomidine, Midazolam, Propofol
- Where
- South Korea
- Volunteers
- 6,963 people
- Sponsor
- Pfizer
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
MRI Sedation
Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans
This is a randomized, double-blind, dose-ranging study of the efficacy and safety of dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric subjects ≥1 month to <17 years of age undergoing…
- Trial name
- NCT04237792
- Testing
- dexmedetomidine, propofol
- Where
- 23 sites in United States, Japan
- Volunteers
- 128 people
- Sponsor
- Pfizer
Preoperative Sedation of Children
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
The study is being conducted to evaluate the efficacy, and safety of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children.
- Trial name
- NCT05111431
- Testing
- Dexmedetomidine Hydrochloride Nasal Spray, Dexmedetomidine hydrochloride nasal spray blank preparation
- Where
- China
- Volunteers
- 159 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
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
Sedation
A Clinical Study of Remimazolam Tosilate in Patients Undergoing Bronchoscopy
A multicenter, randomized, single-blind, active controlled, parallel group study comparing remimazolam tosilate to propofol in patients undergoing bronchoscopy.
- Trial name
- NCT04400201
- Testing
- Remimazolam Tosilate, Propofol
- Where
- China
- Volunteers
- 330 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
Sedation
A Study Evaluating the Efficacy and Safety of HSK3486 for Sedation
This is a multi-center, open-label, randomized, propofol-controlled phase II clinical trial.A total of ICU patients undergoing mechanical ventilation are intended to be enrolled and randomly assigned to HSK3486 group and propofol…
- Trial name
- NCT04147416
- Testing
- HSK3486 0.1-0.2 /0.3 mg / kg group, Propofol 0.5-1.0/1.5 mg/kg group
- Where
- China
- Volunteers
- 39 people
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Sedation in Intensive Care
A Study Evaluating Sedation of Intravenous Administration of HSK3486 Injectable Emulsion in ICU Patients Undergoing Mechanical Ventilation
This is a multi-center, randomized, single-blind, propofol-controlled phase III clinical study. In this study, ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the…
- Trial name
- NCT04620031
- Testing
- HSK3486, Propofol
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Sedation in Intensive Care
A Clinical Study Evaluating Sedation of Intravenous Administration of HSK3486 in ICU Patients Undergoing Long-Term Mechanical Ventilation
This is a multi-center, randomized, open-label, propofol-controlled exploratory clinical study. In this study, 20 ICU patients undergoing mechanical ventilation are expected to be enrolled and will be randomly assigned to the…
- Trial name
- NCT04669821
- Testing
- HSK3486, Propofol
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Local Anesthesia Assisted Sedation
A Trial of Efficacy and Safety of Remimazolam Tosilate for Injection in Local Anesthesia Assisted Sedation
To evaluate the efficacy and safety of Remimazolam Tosilate for injection in local anesthesia assisted sedation, and to explore the dose range of remazolam toluenesulfonate for injection in local anesthesia assisted sedation.
- Trial name
- NCT05015361
- Testing
- Remimazolam Tosilate, Propofol Injection.
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Sedation
Clinical Study to Investigate the Efficacy and the Safety of DA-9501 in Sedation During the Surgery With Epidural Anesthesia or Spinal Anesthesia Without Intubation
The purpose of this study is to examine the efficacy and safety of DA-9501 (Dexmedetomidine) in patients who require sedation during the surgery that requires epidural or spinal anesthesia without intubation under monitored…
- Trial name
- NCT01438957
- Testing
- Dexmedetomidine hydrochloride
- Where
- 12 sites in Japan
- Volunteers
- 119 people
- Sponsor
- Pfizer
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
Sedation or Anesthesia
A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Subjects Undergoing Fiberoptic Bronchoscopy
This is a Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial. Around 260 eligible subjects are planned to be enrolled and randomized in a 1:1 ratio to either the HSK3486 arm or propofol arm.
- Trial name
- NCT04111159
- Testing
- HSK3486, Propofol
- Where
- China
- Volunteers
- 267 people
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Preoperative Sedation
A Trial of Dexmedetomidine Hydrochloride Nasal Spray in Preoperative Sedation of Children
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of dexmedetomidine hydrochloride nasal spray for preoperative sedation in children
- Trial name
- NCT04200235
- Testing
- Dexmedetomidine hydrochloride nasal spray, Dexmedetomidine hydrochloride nasal spray blank preparation.
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Jiangsu HengRui Medicine 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