Clinical trial

Half Effective Dose of Remimazolam to Prevent Cardiovascular Response to Tracheal Intubation When Combined With Fentanyl

Name
XJH-A-20231120
Description
Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl in pediatric patients is still unknown.
Trial arms
Trial start
2023-12-20
Estimated PCD
2024-05-31
Trial end
2024-05-31
Status
Not yet recruiting
Treatment
Remimazolam
remimazolam is given intravenously
Arms:
remimazolam
Other names:
remimazolam besylate
Size
40
Primary endpoint
half effective dose for intubation
from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes
cardiovascular response to tracheal intubation
from injection of remimazolam to 3 minutes after tracheal intubation, at an average of 8 minutes
Eligibility criteria
Inclusion Criteria: * age from 3 to 12 years old * patients scheduled for surgery under general anesthesia * Body mass index in the range of 5% -95% of the same age group * Consent was obtained from the patient and the family members, and an informed consent form was signed Exclusion Criteria: * American Society of Anesthesiologists status ≥3 * patients who cannot cooperate with intravenous anesthesia induction * patients with risk of difficult airway * patients who are allergic to benzodiazepines * patients with neurological dysfunction * Participate involved in other clinical investigators within 3 months
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The initial dose is 0.4mg/kg and the dose interval is 0.2mg/kg', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-12-14

1 organization

1 product

1 indication

Organization
Zhihong Lu
Indication
Anesthesia