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NCT05990673 Clinical Trial

Dose of Remi in Children

Anesthesia Clinical Trial

— DRINK  

Official title:
Determination of the 50% and 95% Effective Dose of Remimazolam for Intravenous Anesthesia Induction in Pediatric Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05990673
Other study ID # XJH-A-20230606
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 10, 2023
Est. completion date September 10, 2023

Study information
Verified date August 2023
Source Air Force Military Medical University, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 25
Est. completion date September 10, 2023
Est. primary completion date September 10, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Years to 12 Years
Eligibility Inclusion Criteria: - age from 3 to 12 years old - patients scheduled for surgery under general anesthesia Exclusion Criteria: - American Society of Anesthesiologists status >=? - 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Remimazolam
remimazolam is given intravenously

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Zhihong LU

References & Publications (1)

Tan H, Lou AF, Wu JE, Chen XZ, Qian XW. Determination of the 50% and 95% Effective Dose of Remimazolam Combined with Propofol for Intravenous Sedation During Day-Surgery Hysteroscopy. Drug Des Devel Ther. 2023 Jun 13;17:1753-1761. doi: 10.2147/DDDT.S40651 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary half effective dosage the dosage by which half of the patients will be sedated from injection of remimazolam to loss of consciousness, at an average of 5 minutes
Secondary 95% effective dosage the dosage by which 95% of the patients will be sedated from injection of remimazolam to loss of consciousness, at an average of 5 minutes
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