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

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Jun 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medicine called Remimazolam to see if it is safe and effective for helping children and teenagers stay calm and comfortable during surgery. The goal is to find out how well this medicine works to sedate (make relaxed or sleepy) young patients while they are having an operation under general anesthesia.

Children and teens who need planned surgery and meet certain health and weight requirements may be able to join the study. To participate, they must be willing to provide consent (or have a parent/guardian do so) and will receive anesthesia through an intravenous (IV) method only. Some patients won’t be eligible, such as those having heart, brain, or liver surgery, or those with certain health issues like asthma or allergies to related medicines. If accepted, participants will receive Remimazolam during their surgery, and the researchers will carefully watch how the medicine works and check for any side effects to ensure it is safe for young patients.

Gender

ALL

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.