Pure Global AI
NCT06370130Completed

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
Aerospace Center HospitalPhase 1ClinicalTrials.govdrug
Study focus
Disease/Condition
Anesthesia
Drug/Device/Intervention
Esketamine 0.2mg/kg
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Aerospace Center Hospital
Location
Beijing, China
Timeline & enrollment
Phase
Phase 1
Start date
May 01, 2022
End date
Mar 10, 2023
Enrollment
58 participants
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
Anaesthetic, unspecifiedOther and unspecified general anaestheticsLocal anaestheticsOther complications of anaesthesiaComplication of anaesthesia during labour and delivery, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06370130
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06370130 through Pure Global AI's free database. This Phase 1 trial is sponsored by Aerospace Center Hospital and is currently Completed. The study focuses on Anesthesia. Target enrollment is 58 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.