Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion - Trial NCT06370130
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Study Focus
Sponsor & Location
Aerospace Center Hospital
Timeline & Enrollment
Phase 1
May 01, 2022
Mar 10, 2023
Primary Outcome
Record of the patient response during LMA placement,Overall condition of LMA placement,Record related indicators,Record related indicators,Record related indicators,Record related indicators,Record of additional doses of propofol and the adverse reactions of positive patients during the induction process (hypotension, bradycardia and apnoea, etc.)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06370130
Non-Device Trial