A Trial of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients
NCT ID: NCT07036419
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
138 participants
INTERVENTIONAL
2025-07-10
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Remimazolam Group
Remimazolam Tosilate for injection
Remimazolam Tosilate for injection.
Propofol Group
Propofol Injection
Propofol injection.
Interventions
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Remimazolam Tosilate for injection
Remimazolam Tosilate for injection.
Propofol Injection
Propofol injection.
Eligibility Criteria
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Inclusion Criteria
2. Subjects requiring elective general anesthesia surgery.
3. Male or female.
4. Meet the weight standard.
Exclusion Criteria
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.
3 Years
17 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HR7056-207
Identifier Type: -
Identifier Source: org_study_id
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