Dose Finding Study of Remifentanil for Laryngeal Mask Airway Insertion During Induction Using Remimazolam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Success/failure of LMA insertion on the first attempt
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Remifentanil
Ambu Auragain inserted after general anesthesia induced with remimazolam and remifentanil
干预措施: Ambu Auragain for airway management (Device)
Remifentanil
Ambu Auragain inserted after general anesthesia induced with remimazolam and remifentanil
干预措施: remifentanil of the assigned dose (Drug)
结局指标
主要结局
Success/failure of LMA insertion on the first attempt
时间窗: 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.
次要结局
- Patient State Index (PSI)(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 coughing(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(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(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)
- Optimality of the LMA insertion based on the administered remifentanil dose(Within one minute after LMA insertion)
- The number of attempts required for successful LMA insertion and whether intubation was performed.(After a stable airway for the surgery has been achieved.)
- Difficulty of LMA insertion(Immediately after LMA insertion)
- Heart rate(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)
- Air leak volume during positive-pressure ventilation(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)
- Severity of hoarseness(30 minutes after admission to the recovery room Outcome measure assemssent - Evaluated as one of 'none', 'mild', 'moderate', or 'severe')