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Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion

NCT06370130 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-04-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Aerospace Center Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06370130 on ClinicalTrials.gov