Remimazolam for sedation during surgery in children and teens

A Clinical Study on Efficacy and Safety of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients

This test tries remimazolam to keep children and adolescents safely sedated during elective general anesthesia.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 3 Years to 17 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (industry)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07036419 on ClinicalTrials.gov

What this trial studies

Children and adolescent patients who require elective general anesthesia at a single center in Shanghai receive remimazolam tosylate for intraoperative sedation, with propofol available as a comparator or rescue agent. The protocol uses total intravenous anesthesia and excludes those scheduled for cardiothoracic, neurosurgical, or hepatic surgery as well as patients with airway, pulmonary, hepatic disease, or known benzodiazepine/propofol allergy. Investigators will monitor depth of sedation, hemodynamic stability, recovery times, and adverse events during surgery and recovery. The sponsor is Jiangsu HengRui Medicine and enrollment is limited to Shanghai Children's Medical Center.

Who should consider this trial

Good fit: Children and adolescents undergoing elective surgery under total intravenous general anesthesia who meet weight requirements and have no major airway, hepatic, or drug-allergy contraindications are ideal candidates.

Not a fit: Patients scheduled for cardiothoracic, neurosurgical, or hepatic procedures, those planned for inhalational or regional anesthesia, or those with significant lab abnormalities or benzodiazepine/propofol allergies are excluded and unlikely to benefit.

Why it matters

Potential benefit: If successful, remimazolam could provide a short-acting, easily titratable sedative with rapid recovery and a favorable safety profile for pediatric intraoperative care.

How similar studies have performed: Remimazolam has shown efficacy and safety for procedural sedation and anesthesia in adults, but pediatric intraoperative use remains limited and less well established.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Lei Tang

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