Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06370130
• Other study ID #: AerospaceCH
• Status: Completed
• Phase: Early Phase 1
• Start date: May 1, 2022
• Est. completion date: March 10, 2023

Study information

• Verified date: April 2024
• Source: Aerospace Center Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 10, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Liang-Yuan Lu	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Aerospace Center Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Record related indicators	Record of the mean arterial pressure (MAP)	1 minutes
Primary	Record related indicators	Record of the mean arterial pressure (MAP)	2 minutes
Primary	Record related indicators	heart rate (HR)	1 minutes
Primary	Record related indicators	heart rate (HR)	2minutes
Primary	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