Operative Sedation of PediatricPhase 2/3NCT07036419
A Trial of Remimazolam for Intraoperative Sedation in Pediatric and Adolescent Patients
A Phase 2/3 study testing Remimazolam Tosilate for injection and Propofol Injection in people with Operative Sedation of Pediatric and Operative Sedation of Adolescent Patients, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Operative Sedation of Pediatric, Operative Sedation of Adolescent Patients
- What is being tested?
- Remimazolam Tosilate for injection and Propofol Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to 27 May 2026
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Able and willing to provide a written informed consent.
- Subjects requiring elective general anesthesia surgery.
- Male or female.
- Meet the weight standard.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200433
About this study
Official title: A Clinical Study on Efficacy and Safety 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.
- Being tested
- Remimazolam Tosilate for injection, Propofol Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remimazolam Tosilate for injectionDrug
Remimazolam Tosilate for injection.
Propofol InjectionDrug
Propofol injection.
| Study group | Role | What they receive |
|---|---|---|
| Remimazolam Group | Experimental | Not described Receives: Drug: Remimazolam Tosilate for injection |
| Propofol Group | Active comparator | Not described Receives: Drug: Propofol Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the anesthesia procedure.
Secondary outcomes (2)
Proportion of subjects with hemodynamic instability.
Defined as a ≥ ±20% change from the baseline in blood pressure or heart rate.
Measured: Up to 2 days.
Incidence and severity of adverse events during the study.
Measured: Up to 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start10 Jul 2025
- Primary completion27 May 2026
- Study completion27 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Operative Sedation of PediatricStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036419
- Sponsor's protocol ID
- HR7056-207
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided