Skip to main content
OpenTrials
Completed

NCT Number: NCT07036419

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Shanghai, Shanghai Municipality, 200433, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Remimazolam Tosilate for injection

Drug

Remimazolam Tosilate for injection.

Propofol Injection

Drug

Propofol injection.

Primary outcomes

  1. The overall sedation success rate.

    Time frame: 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 outcomes

  1. Proportion of subjects with hemodynamic instability.

    Time frame: Up to 2 days.

    Defined as a ≥ ±20% change from the baseline in blood pressure or heart rate.

  2. Incidence and severity of adverse events during the study.

    Time frame: Up to 3 days.

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 25, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.