drugset / Trial / NCT06370130

Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion

NCT06370130

Phase 0 Completed 58 enrolled Aerospace Center Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

Objective To prospectively determine the median effective dose (ED50) of propofol for inhibiting a response to laryngeal mask airway (LMA) insertion when combined with different doses of esketamine in female patients. Methods Fifty-eight female patients (aged 20-60, ASAⅠ-Ⅱ) scheduled for elective hysteroscopy were enrolled and randomly divided into two groups, one administered 0.2 mg/kg of esketamine (K1 group, n = 28) and the other 0.3 mg/kg of esketamine (K2 group, n = 30). The two groups received the corresponding doses of esketamine intravenously, followed by an intravenous injection of propofol (injection time was 30 s). The initial dose of propofol was 2 mg/kg, and the dose ratio of propofol in the adjacent patients was 0.9. If there was a positive reaction to LMA insertion, the dose ratio in the next patient was increased by one gradient, and if not, the dose ratio was decreased by one gradient. The median effective dose (ED50), 95% effective dose (ED95) and 95% confidence interval (95%CI) of propofol for inhibiting a response to LMA insertion in the two esketamine groups were calculated using a probit analysis.

Timeline

Start
2022-05-01
Primary completion
2022-12-20
Completion
2023-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified 0.2 mg/kg Intravenous
Subject Esketamine Other / unclassified 0.3 mg/kg Intravenous

Indications

No indication recorded.