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Completed
NCT06289829
The Appropriate Remifentanil Dose for Optimal Insertion of Laryngeal Mask Airway in Adult Patients During Induction of General Anesthesia Using Remimazolam.
Conditions: Adult, Laryngeal Masks, Remimazolam, Remifentanil
Sex: All
Ages: 19 Years – 64 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Yonsei University
Location: Severance Hospital Seoul
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.
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.
Source: ClinicalTrials.gov (NCT06289829). StuddyBuddy aggregates publicly available trial information.