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Completed

NCT Number: NCT06370130

Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion

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.

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Key information

Conditions

Anesthesia

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Liang-Yuan Lu

Beijing, Beijing Municipality, 100049, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: propofol

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.

Other names: propofol

Primary outcomes

  1. Record of the patient response during LMA placement

    Time frame: 1 minutes

    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.

  2. Overall condition of LMA placement

    Time frame: 1 minutes

    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

  3. Record related indicators

    Time frame: 1 minutes

    Record of the mean arterial pressure (MAP)

  4. Record related indicators

    Time frame: 2 minutes

    Record of the mean arterial pressure (MAP)

  5. Record related indicators

    Time frame: 1 minutes

    heart rate (HR)

  6. Record related indicators

    Time frame: 2minutes

    heart rate (HR)

  7. Record of additional doses of propofol and the adverse reactions of positive patients during the induction process (hypotension, bradycardia and apnoea, etc.)

    Time frame: 1 minutes

    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)

Sponsors and collaborators

Lead sponsor

Aerospace Center Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 17, 2024
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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