Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion

NCT06370130 | Completed Early Phase 1

• 1 other identifier: AerospaceCH
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Esketamine; propofol; median effective dose

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

K1

EXPERIMENTAL

a group administered 0.2 mg/kg of esketamine

Drug: Esketamine 0.2mg/kg

K2

ACTIVE COMPARATOR

a group administered esketamine of 0.3 mg/kg (K2)

Drug: Esketamine 0.3mg/kg

Interventions

Esketamine 0.2mg/kg DRUG

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.

Also known as: propofol

K1

Esketamine 0.3mg/kg DRUG

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.

Also known as: propofol

K2

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aerospace Center Hospital: lead

Study Sites (1)

Liang-Yuan Lu

Beijing, Beijing Municipality, 100049, China

Location

MeSH Terms

Interventions

Esketamine; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 17, 2024
• Study Start: May 1, 2022
• Primary Completion: December 20, 2022
• Study Completion: March 10, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

CN (1)