NCT06370130

Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion

Determation of Median Effective Dose of Propofol Combined With Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion in Female Patients

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Aerospace Center Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anesthesia

Interventions

Type	Name	Description
DRUG	Esketamine 0.2mg/kg	Patients received 0.2 mg/kg of esketamine intravenously for 30 s，after 120 s of propofol and disappearance of the eyelash reflex, a laryngeal mask was inserted. The test was performed using the sequential method. The initial dose of propofol was 2 mg/kg, which can be easily inserted into the LMA, and the propofol dose ratio of the adjacent patient was 0.9. If there was a positive reaction to the LMA insertion, the gradient was increased for the next patient; otherwise, the gradient was decreased, and the study was terminated after seven crossover inflection points.
DRUG	Esketamine 0.3mg/kg	Patients received 0.3 mg/kg of esketamine intravenously for 30 s，after 120 s of propofol and disappearance of the eyelash reflex, a laryngeal mask was inserted. The test was performed using the sequential method. The initial dose of propofol was 2 mg/kg, which can be easily inserted into the LMA, and the propofol dose ratio of the adjacent patient was 0.9. If there was a positive reaction to the LMA insertion, the gradient was increased for the next patient; otherwise, the gradient was decreased, and the study was terminated after seven crossover inflection points.

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-12-20
• Completion: 2023-03-10
• First posted: 2024-04-17
• Last updated: 2024-04-17

Locations

1 site across 1 country: China