Operative Sedation of Pediatric, Operative Sedation of Adolescent Patients
Conditions
Brief summary
The study is being conducted to evaluate the efficacy and safety of Remimazolam for intraoperative sedation in pediatric and adolescent patients.
Interventions
Propofol injection.
Remimazolam Tosilate for injection.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The overall sedation success rate. | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with hemodynamic instability. | Up to 2 days. | Defined as a ≥ ±20% change from the baseline in blood pressure or heart rate. |
| Incidence and severity of adverse events during the study. | Up to 3 days. | — |
Countries
China
Contacts
CONTACTLei Tang
Outcome results
None listed