Severance Hospital
Seoul, South Korea
NCT Number: NCT06289829
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.
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Notify Me19 year–64 year
All sexes
Interventional
Not applicable
Seoul, South Korea
1.Screening Method:
2.Research Method:
(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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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, a type of laryngeal mask airway, will be inserted into every patient after general anesthesia has been induced.
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.
Time frame: Immediately after LMA insertion
Evaluated as one of 'easy', 'moderate', 'difficult', or 'impossible'.
Time frame: Within one minute after LMA insertion
Evaluated as optimal if swallowing, coughing and gagging, head or body movement, and laryngospasm are absent.
Time frame: After a stable airway for the surgery has been achieved.
Time frame: Tidal volume is set to 8mL/kg immediate after LMA insertion.
Inspiratory and expiratory volumes are checked to determine air leak volume and peak inspiratory pressure is measured using the anesthesia machine.
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
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
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
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
Time frame: 30 minutes after admission to the recovery room Outcome measure assemssent - Evaluated as one of 'none', 'mild', 'moderate', or 'severe'
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'
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'
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
Yonsei University
Other
Dose Finding Study of Remifentanil for Laryngeal Mask Airway Insertion During Induction Using Remimazolam
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