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Completed
NCT07036419
A Trial of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients
Conditions: Operative Sedation of Pediatric, Operative Sedation of Adolescent Patients
Sex: All
Ages: 3 Years – 17 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 249
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Location: Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality
Summary
The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients.
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.
Source: ClinicalTrials.gov (NCT07036419). StuddyBuddy aggregates publicly available trial information.