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

Phase 2

Recruiting

• Conditions: Operative Sedation of Pediatric; Operative Sedation of Adolescent Patients
• Interventions: Drug: Remimazolam Tosilate for injection; Drug: Propofol Injection

• Registration Number: NCT07036419
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-16
• Study First Submitted QC: 2025-06-16
• Study First Posted: 2025-06-25
• Status Verified: 2025-07
• Study Start: 2025-07-10
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-23
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remimazolam Group	Remimazolam Tosilate for injection	-
Propofol Group	Propofol Injection	-

Primary Outcome Measures

Name	Time	Method
The overall sedation success rate.	Throughout the anesthesia procedure.	The overall sedation success rate, which encompasses both successful induction of sedation and successful maintenance of adequate sedation throughout the anesthesia procedure.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with hemodynamic instability.	Up to 2 days.	Defined as a ≥ ±20% change from the baseline in blood pressure or heart rate.
Incidence and severity of adverse events during the study.	Up to 3 days.

Trial Locations

Locations (1)

Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China