A Trial of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Operative Sedation of Pediatric; Operative Sedation of Adolescent Patients

Treatments: Drug: Propofol Injection; Drug: Remimazolam Tosilate for injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07036419

HR7056-207

Details and patient eligibility

About

The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients.

Enrollment: 138 estimated patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able and willing to provide a written informed consent.
2. Subjects requiring elective general anesthesia surgery.
3. Male or female.
4. Meet the weight standard.

Exclusion criteria

1. Pediatric patients scheduled for elective cardiothoracic, neurosurgical, or hepatic surgery.
2. 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.
3. 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.
4. Patients with a history of asthma or with risk for difficult mask ventilation or difficult intubation by the investigator's judgment.
5. With clinically significant abnormal clinical laboratory test value.
6. Known intolerance or allergy to benzodiazepines, propofol, opioids, neuromuscular blocking agents, or any of their components.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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138 participants in 2 patient groups

Remimazolam Group

Experimental group

Treatment:

Drug: Remimazolam Tosilate for injection

Propofol Group

Active Comparator group

Treatment:

Drug: Propofol Injection