NCT05990673Not yet recruitingNot Applicable
Determination of the 50% and 95% Effective Dose of Remimazolam for Intravenous Anesthesia Induction in Pediatric Patients
Zhihong LU0 sites25 target enrollmentStarted: August 10, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 25
- Primary Endpoint
- half effective dosage
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
remimazolam
Experimental
remimazolam is given for anesthesia induction
Intervention: Remimazolam (Drug)
Outcomes
Primary Outcomes
half effective dosage
Time Frame: from injection of remimazolam to loss of consciousness, at an average of 5 minutes
the dosage by which half of the patients will be sedated
Secondary Outcomes
- 95% effective dosage(from injection of remimazolam to loss of consciousness, at an average of 5 minutes)
Investigators
Zhihong LU
Associate professor
Air Force Military Medical University, China
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