Clinical trial
Determination of the 50% and 95% Effective Dose of Remimazolam for Intravenous Anesthesia Induction in Pediatric Patients
Name
XJH-A-20230606
Description
Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, the effective dosage of remimazolam in pediatric patients is still unknown.
Trial arms
Trial start
2023-08-10
Estimated PCD
2023-09-10
Trial end
2023-09-10
Status
Not yet recruiting
Treatment
Remimazolam
remimazolam is given intravenously
Arms:
remimazolam
Other names:
remimazolam besylate
Size
25
Primary endpoint
half effective dosage
from injection of remimazolam to loss of consciousness, at an average of 5 minutes
Eligibility criteria
Inclusion Criteria:
* age from 3 to 12 years old
* patients scheduled for surgery under general anesthesia
Exclusion Criteria:
* American Society of Anesthesiologists status \>=Ⅲ
* Body mass index\>=28kg/m2
* patients who cannot cooperate with intravenous anesthesia induction
* patients with risk of difficult airway
* patients who are allergic to benzodiazepines
* patients with delayed neurologic function
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ESTIMATED'}}
Updated at
2023-08-14
1 organization
1 product
1 indication
Organization
Zhihong LuProduct
RemimazolamIndication
Anesthesia