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
Operative Sedation of Pediatric, Operative Sedation of Adolescent Patients
A Trial of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients
The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients.
- Trial name
- NCT07036419
- Testing
- Remimazolam Tosilate for injection, Propofol Injection
- Where
- China
- Volunteers
- 249 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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
The Study is Being Conducted to Evaluate the Efficacy and Safety of Dexmedetomidine Hydrochloride Microneedles for Preoperative Sedation in Children
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children
- Trial name
- NCT07168720
- Testing
- Dexmedetomidine hydrochloride Microneedles
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Guangzhou Novaken Pharm Co., Ltd.
Sedation
A Study to Learn About the Study Medicine - Precedex in Children From Japan.
The purpose of this study is to look at the safety of Precedex when it was used to calm children at procedures or tests under actual medical practice in Japan.
- Trial name
- NCT06085573
- Testing
- Dexmedetomidine Hydrochloride
- Where
- Japan
- Volunteers
- 111 people
- Sponsor
- Pfizer
Sedation
Effect & Safety of Inhaled Isoflurane vs IV Midazolam for Sedation in Mechanically Ventilated Children 3-17 Years Old
This is a study to compare safety and efficacy of inhaled isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device (ACD)) versus intravenous midazolam for sedation in mechanically ventilated children admitted to an…
- Trial name
- IsoCOMFORT (NCT04684238)
- Testing
- Midazolam, Isoflurane
- Where
- 24 sites in France, Germany and 3 more
- Volunteers
- 94 people
- Sponsor
- Sedana Medical
Sedation
Precedex Special Investigation (in Pediatric Patients)
Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.
- Trial name
- NCT04040439
- Testing
- Dexmedetomidine Hydrochloride
- Where
- Japan
- Volunteers
- 111 people
- Sponsor
- Pfizer
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
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.
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.
ICU Sedation
Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU
Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing registration of Dexdor
- Trial name
- Pedrux (NCT03813277)
- Testing
- Dexmedetomidine
- Where
- Russia
- Volunteers
- 60 people
- Sponsor
- Orion Corporation, Orion Pharma
ICU Sedation
Study of DA-9501 In Pediatric Subjects In The Intensive Care Unit
To evaluate the efficacy, safety, and pharmacokinetics of dexmedetomidine given as continuous IV infusion in pediatric subjects [≥ 45 weeks CGA (corrected gestational age) to <17 years old] requiring sedation under intensive care…
- Trial name
- NCT02757625
- Testing
- Dexmedetomidine hydrochloride
- Where
- 12 sites in Japan
- Volunteers
- 63 people
- Sponsor
- Pfizer
Sedation
Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects.
- Trial name
- NCT00875550
- Testing
- Dexmedetomidine, Midazolam, Fentanyl
- Where
- 37 sites in United States, Canada
- Volunteers
- 175 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Sedation
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading…
- Trial name
- NCT01159262
- Testing
- Midazolam, Fentanyl/Morphine, Dexmedetomidine
- Where
- 18 sites in United States, Guatemala
- Volunteers
- 36 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Sedation, Pain
Phase II Pharmacokinetic and Pharmacodynamic Study of DEX in Subjects Aged 12 Months Through <24 Months
The purpose of this study is to investigate the pharmacokinetic, pharmacodynamic, and safety of dexmedetomidine at 2 different dose levels in pediatric subjects, aged 12 months through <24 months, administered as an intravenous…
- Trial name
- NCT01378988
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer