AnesthesiaEarly Phase 1NCT06370130
Different Dose of Esketamine Inhibiting Response to Laryngeal Mask Airway Insertion
A Early Phase 1 study testing Esketamine 0.2mg/kg and Esketamine 0.3mg/kg in people with Anesthesia, run by Aerospace Center Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Esketamine 0.2mg/kg and Esketamine 0.3mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 10 Mar 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Esketamine 0.2mg/kg, Esketamine 0.3mg/kg
- Keywords
- Esketamine, propofol, median effective dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine 0.2mg/kgDrug
Also called propofol
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/kgDrug
Also called propofol
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.
| Study group | Role | What they receive |
|---|---|---|
| K1 | Experimental | a group administered 0.2 mg/kg of esketamine Receives: Drug: Esketamine 0.2mg/kg |
| K2 | Active comparator | a group administered esketamine of 0.3 mg/kg (K2) Receives: Drug: Esketamine 0.3mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 minutes
Record related indicators
Record of the mean arterial pressure (MAP)
Measured: 1 minutes
Record related indicators
Record of the mean arterial pressure (MAP)
Measured: 2 minutes
Record related indicators
heart rate (HR)
Measured: 1 minutes
Record related indicators
heart rate (HR)
Measured: 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)
Measured: 1 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 May 2022
- Primary completion20 Dec 2022
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerospace Center Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370130
- Sponsor's protocol ID
- AerospaceCH
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06370130
- Acronym / sponsor ID
- AerospaceCH
- Conditions
- Anesthesia
- Keywords
- Esketamine, propofol, median effective dose
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Aerospace Center HospitalUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| K1 | Experimental | Drug: Esketamine 0.2mg/kga group administered 0.2 mg/kg of esketamine |
| K2 | Active comparator | Drug: Esketamine 0.3mg/kga group administered esketamine of 0.3 mg/kg (K2) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esketamine 0.2mg/kgAlso: propofolPatients 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. | Drug | K1 |
| Esketamine 0.3mg/kgAlso: propofolPatients 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. | Drug | K2 |
Primary outcome
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.
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
Record related indicators
Time frame: 1 minutes
Record of the mean arterial pressure (MAP)
Record related indicators
Time frame: 2 minutes
Record of the mean arterial pressure (MAP)
Record related indicators
Time frame: 1 minutes
heart rate (HR)
Record related indicators
Time frame: 2minutes
heart rate (HR)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Esketamine 0.2mg/kg and Esketamine 0.3mg/kg in people with Anesthesia, run by Aerospace Center Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Record of the patient response during LMA placement (time frame: 1 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.