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

NCT07036419 | Recruiting Phase 2

• 1 other identifier: HR7056-207
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Operative Sedation of Pediatric; Operative Sedation of Adolescent Patients

Outcome Measures

Primary Outcomes (1)

• The overall sedation success rate.

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

  Throughout the anesthesia procedure.

Secondary Outcomes (2)

• Proportion of subjects with hemodynamic instability.

  Up to 2 days.

• Incidence and severity of adverse events during the study.

  Up to 3 days.

Study Arms (2)

Remimazolam Group

EXPERIMENTAL

Drug: Remimazolam Tosilate for injection

Propofol Group

ACTIVE COMPARATOR

Drug: Propofol Injection

Interventions

Propofol Injection DRUG

Propofol injection.

Propofol Group

Remimazolam Tosilate for injection DRUG

Remimazolam Tosilate for injection.

Remimazolam Group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Interventions

Injections; Propofol

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Lei Tang

CONTACT

+86-0518-82342973; lei.tang.lt31@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: June 25, 2025
• Study Start: July 10, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

CN (1)