The Appropriate Remifentanil Dose for Optimal Insertion of Laryngeal Mask Airway in Adult Patient… (NCT06289829) | Clinical Trial Compass
CompletedNot Applicable
The Appropriate Remifentanil Dose for Optimal Insertion of Laryngeal Mask Airway in Adult Patients During Induction of General Anesthesia Using Remimazolam.
South Korea60 participantsStarted 2024-04-04
Plain-language 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.
Who can participate
Age range
19 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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