Anesthesia
Conditions
Keywords
anesthesia induction, remimazolam, tracheal intubation, median effective dose
Brief summary
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.
Interventions
DRUGRemimazolam
remimazolam is given intravenously
Sponsors
Zhihong LU
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The initial dose is 0.4mg/kg and the dose interval is 0.2mg/kg
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| half effective dose for intubation | from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes | half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl |
| cardiovascular response to tracheal intubation | from injection of remimazolam to 3 minutes after tracheal intubation, at an average of 8 minutes | cardiovascular response is defined as increase of blood pressure or heart rate higher than 20% of the baseline value by 3 minutes after intubation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the time to loss of consciousness | from injection of remimazolam to loss of consciousness, at an average of 3 minutes | — |
| incidence of adverse events | from injection of remimazolam to loss of consciousness, at an average of 3 minutes | adverse events include bradycardia, hypotension, hypoxemia, and injection pain |
Outcome results
None listed