Adult, Laryngeal Masks, Remimazolam, RemifentanilNCT06289829
The Appropriate Remifentanil Dose for Optimal Insertion of Laryngeal Mask Airway in Adult Patients During Induction of General Anesthesia Using Remimazolam.
A study testing remifentanil of the assigned dose and Ambu Auragain for airway management in people with Adult, Laryngeal Masks, Remimazolam, Remifentanil, run by Yonsei University at 1 site in South Korea.
Trial summary
The laryngeal mask airway (LMA) is an airway maintenance device that is easy to insert and has the advantage of causing less sore throat and autonomic nervous system stimulation. To appropriately insert the LMA, an adequate depth of anesthesia is essential. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Adult, Laryngeal Masks, Remimazolam, Remifentanil
- What is being tested?
- remifentanil of the assigned dose and Ambu Auragain for airway management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Apr 2024to 12 Mar 2026
- Phase
- Interventional
- 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 19 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 19 years or older and less than 65 years
- ASA physical status classification I, II, or III
- Scheduled for elective surgery lasting within 3 hours under general anesthesia using a laryngeal mask
Who cannot join
- Refusal to participate in the study
- Unable to read the consent form or comprehend the research process (e.g., illiteracy, foreign nationality, cognitive impairment)
- Anatomic structures that are anticipated to cause difficulty in mask ventilation
- History of difficulty in airway management
- Upper respiratory infections or respiratory conditions (e.g., asthma, pneumonia)
- Risk of aspiration (e.g., gastroesophageal reflux)
Show all 11Show fewer
- Allergies to anesthesia-related drugs, such as benzodiazepines or opioid analgesics
- Impaired liver or kidney function
- Pregnant or breastfeeding patients
- Obesity (body mass index > 30 kg/m2)
- History of drug or alcohol abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Finding Study of Remifentanil for Laryngeal Mask Airway Insertion During Induction Using Remimazolam
The laryngeal mask airway (LMA) is an airway maintenance device that is easy to insert and has the advantage of causing less sore throat and autonomic nervous system stimulation. To appropriately insert the LMA, an adequate depth of anesthesia is essential. Various drugs have been studied for inducing anesthesia to achieve the appropriate depth for LMA insertion, and the newly developed benzodiazepine, remimazolam, is gaining attention as one of them. Remimazolam has rapid onset and recovery times, hemodynamic stability, and is often co-administered with opioids like remifentanil for more effective LMA insertion. This study aims to find the optimal dose of remifentanil for the proper insertion of the Ambu Auragain, one of the recently developed LMAs, during induction of anesthesia using remimazolam and the Biased-Coin Up-and-Down method will be used for this purpose. Starting with an initial concentration of remifentanil of 3.0 μg/mL, the success or failure of LMA insertion will determine the dosage for the next subject. Data will be collected from a total of 60 patients, and subsequent analysis will be conducted.
Read the detailed description
1.Screening Method:
- Subject screening is conducted based on the results of general preoperative tests, including checking the patient's medical and medication history, routine blood tests, general chemistry and coagulation tests, electrocardiogram (ECG), chest X-ray, etc.
- Subjects are selected from adult patients undergoing elective surgery under general anesthesia using the LMA within 3 hours.
- Patients are visited the day before the surgery. Information about the study is provided and patients are allowed sufficient time for deciding participation until arriving at the operating room. Informed consent for the participation is achieved on the morning of surgery.
2.Research Method:
- Monitoring devices, including electrocardiogram, non-invasive blood pressure monitor, pulse oximeter, and SedLine® brain function monitor (Masimo, Irvine, CA), are applied for patient monitoring according to standard care.
- Proper insertion of the intravenous catheter in the patient is confirmed. The intravenous line is connected to remifentanil and remimazolam (diluted to concentrations of 20μg/mL and 1mg/mL respectively) using syringe pumps. (3)100% oxygen is administered at 6L/min for 3 minutes for preoxygenation. (4)Continuous infusion of remifentanil is started using Target-Controlled Infusion (TCI) with the Minto model, adjusting the effect-site concentration based on the biased-coin up-and-down method. The initial concentration for the first patient is 3.0μg/mL. Subsequent doses are determined based on the success or failure of the previous subject's LMA insertion. 0.3mg/kg of remimazolam is simultaneously administered over approximately 10-20 seconds. (5)100% oxygen is supplied through a facemask and manual ventilation is performed if necessary. When the desired effect-site concentration of remifentanil is confirmed 120 seconds after remimazolam administration, LMA is inserted. The LMA used for the procedure is Ambu®AuraGainTM (Ambu A/S, Ballerup, Denmark). The size of the LMA is selected according to the manufacturer's guide and lubricating jelly is applied on the LMA before the insertion. (6)If the LMA is determined to obstruct the airway or be malpositioned, it is removedand mask ventilation is reengaged. The effect-site concentration of remifentanil is increased by 0.3μg/mL, and one minute later, the LMA is inserted for the second time using the same procedure. If the insertion proves unsuccessful despite three attempts following the same approach, tracheal intubation is performed. (7)Data are collected during LMA insertion and maintenance. Continuous infusion of remimazolam and remifentanil is conducted to maintain PSI score in the range of 25-50 during the surgery. Infusion of the anesthetic agents are stopped when the surgery is finished. The LMA is removed after spontaneous breathing is confirmed and the patient is transferred to the recovery room.
- Being tested
- remifentanil of the assigned dose, Ambu Auragain for airway management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remifentanil of the assigned doseDrug
Ambu Auragain will be inserted after general anesthesia is induced with remimazolam and remifentanil. Each patient will be assigned with a certain dose of remifentanil, according to whether the previous patient's LMA insertion process was successful or not.
Ambu Auragain for airway managementDevice
Ambu Auragain, a type of laryngeal mask airway, will be inserted into every patient after general anesthesia has been induced.
| Study group | Role | What they receive |
|---|---|---|
| Remifentanil | Other | Ambu Auragain inserted after general anesthesia induced with remimazolam and remifentanil Receives: Drug: remifentanil of the assigned dose; Device: Ambu Auragain for airway management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success/failure of LMA insertion on the first attempt
LMA insertion is assessed as 'successful' when the following criteria are satisfied.
- Absence of bucking, laryngospasm, or movements of the head or the limbs during the insertion.
- Mouth opening is evaluated as 1 or 2 according to the Muzi score. (Muzi score: 1 fully relaxed, 2 mild resistance, 3 tight but opens, 4 closed)
- Symmetrical chest wall movement and a rectangular capnographic wave is seen when manual ventilation conducted via the inserted LMA.
Measured: LMA insertion is assessed after inserting the LMA and conducting manual ventilation via the LMA
Secondary outcomes (11)
Difficulty of LMA insertion
Evaluated as one of 'easy', 'moderate', 'difficult', or 'impossible'.
Measured: Immediately after LMA insertion
Optimality of the LMA insertion based on the administered remifentanil dose
Evaluated as optimal if swallowing, coughing and gagging, head or body movement, and laryngospasm are absent.
- 'Swallowing' is evaluated as one of 'absent', 'slight', or 'gross'
- 'Coughing and gagging' is evaluated as one of 'absent', 'slight', or 'gross'
- 'Head or body movement' is evaluated as one of 'absent', 'slight', or 'gross'
- 'Laryngospasm' is evaluated as one of 'absent', 'partial', or 'total'
Measured: Within one minute after LMA insertion
The number of attempts required for successful LMA insertion and whether intubation was performed.
Measured: After a stable airway for the surgery has been achieved.
Air leak volume during positive-pressure ventilation
Inspiratory and expiratory volumes are checked to determine air leak volume and peak inspiratory pressure is measured using the anesthesia machine.
Measured: Tidal volume is set to 8mL/kg immediate after LMA insertion.
Systolic blood pressure
Baseline before induction of anesthesia, immediately before LMA insertion, immediately after successful LMA insertion, 10 minutes after LMA insertion, end of the surgery, 30 minutes after admission to the recovery room
Measured: Baseline before induction of anesthesia, immediately before LMA insertion, immediately after successful LMA insertion, 10 minutes after LMA insertion, end of the surgery, 30 minutes after admission to the recovery room
Heart rate
Measured: Baseline before induction of anesthesia, immediately before LMA insertion, immediately after successful LMA insertion, 10 minutes after LMA insertion, end of the surgery, 30 minutes after admission to the recovery room
Patient State Index (PSI)
Measured: Baseline before induction of anesthesia, immediately before LMA insertion, immediately after successful LMA insertion, 10 minutes after LMA insertion, End of the surgery, 30 minutes after admission to the recovery room
Severity of hoarseness
Measured: 30 minutes after admission to the recovery room Outcome measure assemssent - Evaluated as one of 'none', 'mild', 'moderate', or 'severe'
Severity of coughing
Measured: 30 minutes after admission to the recovery room Outcome measure assemssent - Evaluated as one of 'none', 'less than a common cold', 'similar to a common cold', or 'more than a common cold'
Severity of sore throat
Measured: 30 minutes after admission to the recovery room Outcome measure assemssent - Evaluated as one of 'none', 'less than a common cold', 'similar to a common cold', or 'more than a common cold'
Diastolic blood pressure
Measured: Baseline before induction of anesthesia, immediately before LMA insertion, immediately after successful LMA insertion, 10 minutes after LMA insertion, end of the surgery, 30 minutes after admission to the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start4 Apr 2024
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult, Laryngeal Masks, Remimazolam, RemifentanilStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289829
- Sponsor's protocol ID
- 4-2023-1605
- Status last verified
- Jun 2026
- First submitted
- 7 Feb 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Finding Study of Remifentanil for Laryngeal Mask Airway Insertion During Induction Using Remimazolam
- ClinicalTrials.gov ID
- NCT06289829
- Acronym / sponsor ID
- 4-2023-1605
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 4 Mar 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.
The laryngeal mask airway (LMA) is an airway maintenance device that is easy to insert and has the advantage of causing less sore throat and autonomic nervous system stimulation. To appropriately insert the LMA, an adequate depth of anesthesia is essential. Various drugs have been studied for inducing anesthesia to achieve the appropriate depth for LMA insertion, and the newly developed benzodiazepine, remimazolam, is gaining attention as one of them. Remimazolam has rapid onset and recovery times, hemodynamic stability, and is often co-administered with opioids like remifentanil for more effective LMA insertion. This study aims to find the optimal dose of remifentanil for the proper insertion of the Ambu Auragain, one of the recently developed LMAs, during induction of anesthesia using remimazolam and the Biased-Coin Up-and-Down method will be used for this purpose. Starting with an initial concentration of remifentanil of 3.0 μg/mL, the success or failure of LMA insertion will determine the dosage for the next subject. Data will be collected from a total of 60 patients, and subsequent analysis will be conducted.
Detailed description
1.Screening Method:
- Subject screening is conducted based on the results of general preoperative tests, including checking the patient's medical and medication history, routine blood tests, general chemistry and coagulation tests, electrocardiogram (ECG), chest X-ray, etc.
- Subjects are selected from adult patients undergoing elective surgery under general anesthesia using the LMA within 3 hours.
- Patients are visited the day before the surgery. Information about the study is provided and patients are allowed sufficient time for deciding participation until arriving at the operating room. Informed consent for the participation is achieved on the morning of surgery.
2.Research Method:
- Monitoring devices, including electrocardiogram, non-invasive blood pressure monitor, pulse oximeter, and SedLine® brain function monitor (Masimo, Irvine, CA), are applied for patient monitoring according to standard care.
- Proper insertion of the intravenous catheter in the patient is confirmed. The intravenous line is connected to remifentanil and remimazolam (diluted to concentrations of 20μg/mL and 1mg/mL respectively) using syringe pumps. (3)100% oxygen is administered at 6L/min for 3 minutes for preoxygenation. (4)Continuous infusion of remifentanil is started using Target-Controlled Infusion (TCI) with the Minto model, adjusting the effect-site concentration based on the biased-coin up-and-down method. The initial concentration for the first patient is 3.0μg/mL. Subsequent doses are determined based on the success or failure of the previous subject's LMA insertion. 0.3mg/kg of remimazolam is simultaneously administered over approximately 10-20 seconds. (5)100% oxygen is supplied through a facemask and manual ventilation is performed if necessary. When the desired effect-site concentration of remifentanil is confirmed 120 seconds after remimazolam administration, LMA is inserted. The LMA used for the procedure is Ambu®AuraGainTM (Ambu A/S, Ballerup, Denmark). The size of the LMA is selected according to the manufacturer's guide and lubricating jelly is applied on the LMA before the insertion. (6)If the LMA is determined to obstruct the airway or be malpositioned, it is removedand mask ventilation is reengaged. The effect-site concentration of remifentanil is increased by 0.3μg/mL, and one minute later, the LMA is inserted for the second time using the same procedure. If the insertion proves unsuccessful despite three attempts following the same approach, tracheal intubation is performed. (7)Data are collected during LMA insertion and maintenance. Continuous infusion of remimazolam and remifentanil is conducted to maintain PSI score in the range of 25-50 during the surgery. Infusion of the anesthetic agents are stopped when the surgery is finished. The LMA is removed after spontaneous breathing is confirmed and the patient is transferred to the recovery room.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remifentanil | Other | Drug: remifentanil of the assigned dose, Device: Ambu Auragain for airway managementAmbu Auragain inserted after general anesthesia induced with remimazolam and remifentanil |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients aged 19 years or older and less than 65 years
- ASA physical status classification I, II, or III
- Scheduled for elective surgery lasting within 3 hours under general anesthesia using a laryngeal mask
Key exclusion criteria (11 listed)
- Refusal to participate in the study
- Unable to read the consent form or comprehend the research process (e.g., illiteracy, foreign nationality, cognitive impairment)
- Anatomic structures that are anticipated to cause difficulty in mask ventilation
- History of difficulty in airway management
- Upper respiratory infections or respiratory conditions (e.g., asthma, pneumonia)
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 |
|---|---|---|
| remifentanil of the assigned doseAmbu Auragain will be inserted after general anesthesia is induced with remimazolam and remifentanil. Each patient will be assigned with a certain dose of remifentanil, according to whether the previous patient's LMA insertion process was successful or not. | Drug | Remifentanil |
| Ambu Auragain for airway managementAmbu Auragain, a type of laryngeal mask airway, will be inserted into every patient after general anesthesia has been induced. | Device | Remifentanil |
Primary outcome
Success/failure of LMA insertion on the first attempt
Time frame: LMA insertion is assessed after inserting the LMA and conducting manual ventilation via the LMA
LMA insertion is assessed as 'successful' when the following criteria are satisfied. * Absence of bucking, laryngospasm, or movements of the head or the limbs during the insertion. * Mouth opening is evaluated as 1 or 2 according to the Muzi score. (Muzi score: 1 fully relaxed, 2 mild resistance, 3 tight but opens, 4 closed) * Symmetrical chest wall movement and a rectangular capnographic wave is seen when manual ventilation conducted via the inserted LMA.
11 secondary outcomes
Difficulty of LMA insertion
Time frame: Immediately after LMA insertion
Optimality of the LMA insertion based on the administered remifentanil dose
Time frame: Within one minute after LMA insertion
The number of attempts required for successful LMA insertion and whether intubation was performed.
Time frame: After a stable airway for the surgery has been achieved.
Air leak volume during positive-pressure ventilation
Time frame: Tidal volume is set to 8mL/kg immediate after LMA insertion.
Systolic blood pressure
Time frame: Baseline before induction of anesthesia, immediately before LMA insertion, immediately after successful LMA insertion, 10 minutes after LMA insertion, end of the surgery, 30 minutes after admission to the recovery room
Heart rate
Time frame: Baseline before induction of anesthesia, immediately before LMA insertion, immediately after successful LMA insertion, 10 minutes after LMA insertion, end of the surgery, 30 minutes after admission to the recovery room
Patient State Index (PSI)
Time frame: Baseline before induction of anesthesia, immediately before LMA insertion, immediately after successful LMA insertion, 10 minutes after LMA insertion, End of the surgery, 30 minutes after admission to the recovery room
Severity of hoarseness
Time frame: 30 minutes after admission to the recovery room Outcome measure assemssent - Evaluated as one of 'none', 'mild', 'moderate', or 'severe'
Severity of coughing
Time frame: 30 minutes after admission to the recovery room Outcome measure assemssent - Evaluated as one of 'none', 'less than a common cold', 'similar to a common cold', or 'more than a common cold'
Severity of sore throat
Time frame: 30 minutes after admission to the recovery room Outcome measure assemssent - Evaluated as one of 'none', 'less than a common cold', 'similar to a common cold', or 'more than a common cold'
Diastolic blood pressure
Time frame: Baseline before induction of anesthesia, immediately before LMA insertion, immediately after successful LMA insertion, 10 minutes after LMA insertion, end of the surgery, 30 minutes after admission to the recovery room
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 1 Jul 2026.
- Individual participant dataSharing planned: No
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 study testing remifentanil of the assigned dose and Ambu Auragain for airway management in people with Adult, Laryngeal Masks, Remimazolam, Remifentanil, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 11 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 1 Jul 2026. 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 South Korea. 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.
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?
Success/failure of LMA insertion on the first attempt (time frame: LMA insertion is assessed after inserting the LMA and conducting manual ventilation via the LMA). 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 1 Jul 2026.