drugset / Trial / NCT05527314
Effect of Remimazolam vs Sevoflurane Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery
RandomizedParallel-groupDouble-blindPrevention
Summary
As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to the traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether Remimazolam reduces the incidence of emergence agitation in children after ophthalmic surgery, compared to sevoflurane (RCT).
Timeline
- Start
- 2022-08-23
- Primary completion
- 2023-02-06
- Completion
- 2023-02-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Remimazolam | Small molecule | 1 mg/kg | Intravenous |
| Subject | Remimazolam | Small molecule | 2 mg/kg | Intravenous |
| Comparator | Sevoflurane | Other / unclassified | 2 % | Inhaled |
| Comparator | Sevoflurane | Other / unclassified | 3 % | Inhaled |
| Background | Cisatracurium | Small molecule | 0.02 mg/kg | Intravenous |
| Background | Fentanyl | Other / unclassified | 3 ug/kg | Intravenous |
| Background | Fentanyl | Other / unclassified | 4 ug/kg | Intravenous |
| Background | Remifentanil | Small molecule | 0.1 ug/kg | Intravenous |
| Background | Remifentanil | Small molecule | 0.3 ug/kg | Intravenous |
Indications
No indication recorded.