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)

Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT07036419