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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Esketamine 0.2mg/kg; Drug: Esketamine 0.3mg/kg

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100049
      • Liang-Yuan Lu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• women undergoing gynaecological hysteroscopy and surgery resulting from any indication
• age: from 20 to 60 years old
• body mass index (BMI): 18-30 kg/m2
• American Society of Anesthesiologists Physical Status score: grade I-II
• voluntary participation in this study

Exclusion Criteria:

• pregnant and lactating women
• patients with a history of propofol allergy, uncontrolled hypertension, hyperthyroidism, severe cardiopulmonary diseases, airway stenosis and mental diseases
• those who have recently taken or are taking psychotropic drugs or analgesic drugs
• patients allergic to or addicted to esketamine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: K1; a group administered 0.2 mg/kg of esketamine	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.; Other Names: propofol
Active Comparator: K2; a group administered esketamine of 0.3 mg/kg (K2)	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.; Other Names: propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Record of the patient response during LMA placement	body movement or no body movement. Body movement is defined as cough, breath-holding or laryngospasm when the LMA is inserted or the laryngeal cuff inflated, and the patient has difficulty opening the mouth and conscious movement all over the body. No body movement is defined as the absence of these reactions when the LMA is inserted or the laryngeal cuff is inflated.	1 minutes
Overall condition of LMA placement	mouth opening ≥3 cm is complete and <3 cm is incomplete. The LMA placement conditions are as follows: 1 = complete relaxation, 2 = mild resistance, 3 = resistance but can open the mouth, 4 = resistance and the need to further increase the propofol dose; 1 and 2 are considered successful LMA placement and 3 and 4 are failure	1 minutes
Record related indicators	Record of the mean arterial pressure (MAP)	1 minutes
Record related indicators	Record of the mean arterial pressure (MAP)	2 minutes
Record related indicators	heart rate (HR)	1 minutes
Record related indicators	heart rate (HR)	2minutes
Record of additional doses of propofol and the adverse reactions of positive patients during the induction process (hypotension, bradycardia and apnoea, etc.)	If the patient develops bradycardia (<45 beats/min), 0.3-0.5 mg of intravenous atropine is given, and 1-2 mg of intravenous dopamine is administered for hypotension (<20% of basal blood pressure)	1 minutes

Collaborators and Investigators

• Sponsor: Aerospace Center Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): March 10, 2023

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 15, 2024
• First Posted (Actual): April 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: propofol; Esketamine; median effective dose
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Psychotropic Drugs; Antidepressive Agents; Hypnotics and Sedatives; Propofol; Esketamine
• Other Study ID Numbers: AerospaceCH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No