Clinical trial NCT06289829: The Appropriate Remifentanil Dose for Optimal Insertion of Laryngeal Mask Airway in Adult Patients During Induction of General Anesthesia Using Remimazolam.
Official title: Dose Finding Study of Remifentanil for Laryngeal Mask Airway Insertion During Induction Using Remimazolam
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adult, Laryngeal Masks, Remimazolam, Remifentanil
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 67
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief 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. 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:

1. 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.
2. Subjects are selected from adult patients undergoing elective surgery under general anesthesia using the LMA within 3 hours.
3. 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:

1. 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.
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
* 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.

Primary outcomes:
measure: Success/failure of LMA insertion on the first attempt
timeFrame: LMA insertion is assessed after inserting the LMA and conducting manual ventilation via the LMA
Secondary outcomes:
measure: Difficulty of LMA insertion
timeFrame: Immediately after LMA insertion
measure: Optimality of the LMA insertion based on the administered remifentanil dose
timeFrame: Within one minute after LMA insertion
measure: The number of attempts required for successful LMA insertion and whether intubation was performed.
timeFrame: After a stable airway for the surgery has been achieved.
measure: Air leak volume during positive-pressure ventilation
timeFrame: Tidal volume is set to 8mL/kg immediate after LMA insertion.
measure: Systolic blood pressure
timeFrame: 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
measure: Heart rate
timeFrame: 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
measure: Patient State Index (PSI)
timeFrame: 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
measure: Severity of hoarseness
timeFrame: 30 minutes after admission to the recovery room Outcome measure assemssent - Evaluated as one of 'none', 'mild', 'moderate', or 'severe'
measure: Severity of coughing
timeFrame: 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'
measure: Severity of sore throat
timeFrame: 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'
measure: Diastolic blood pressure
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References: