RecruitingPhase 2Phase 3NCT07036419
A Trial of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients
A Clinical Study on Efficacy and Safety of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Enrollment
240 participants
Start Date
Jul 10, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients.
Eligibility
Min Age: 3 YearsMax Age: 17 Years
Inclusion Criteria4
- Able and willing to provide a written informed consent.
- Subjects requiring elective general anesthesia surgery.
- Male or female.
- Meet the weight standard.
Exclusion Criteria6
- Pediatric patients scheduled for elective cardiothoracic, neurosurgical, or hepatic surgery.
- Patients who are planned to receive any anesthetic techniques other than total intravenous anesthesia (TIVA) from entry into the operating room until the end of surgery, such as inhalational anesthesia, epidural anesthesia, or spinal anesthesia.
- Patients with a medical history or clinical evidence that may increase the risk of sedation or anesthesia and are deemed unsuitable for participation by the investigator.
- Patients with a history of asthma or with risk for difficult mask ventilation or difficult intubation by the investigator's judgment.
- With clinically significant abnormal clinical laboratory test value.
- Known intolerance or allergy to benzodiazepines, propofol, opioids, neuromuscular blocking agents, or any of their components.
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Interventions
DRUGRemimazolam Tosilate for injection
Remimazolam Tosilate for injection.
DRUGPropofol Injection
Propofol injection.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07036419