90% Effective Dose of Tegileridine Combined With Propofol for Inhibiting Laryngeal Mask Airway Insertion Responses in Patients of Different Ages: A Biased-Coin Sequential Allocation Dose-Finding Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- 90% Effective Dose (ED90) of Tegileridine for Suppressing Laryngeal Mask Airway Insertion Response
研究概览
简要总结
This is a prospective two-group dose-finding trial using biased-coin sequential up-and-down design. We plan to enroll 108 patients who need general anesthesia with laryngeal mask airway placement, divided into young group (18-64 years old) and elderly group (65 years old and older). All patients will receive tegileridine combined with fixed-dose propofol for anesthesia induction. The main goal is to find the 90% effective dose (ED90) of tegileridine that can fully block body movement, cough, tearing and unstable blood pressure/heart rate during laryngeal mask insertion. We will also record cough rate, hemodynamic changes, sedation depth and all perioperative adverse reactions to provide safe dosing reference for different age patients in clinical anesthesia.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgery requiring general anesthesia with laryngeal mask airway insertion
- •Age ≥ 18 years
- •American Society of Anesthesiologists (ASA) physical status I-III
排除标准
- •At rest in the operating room, systolic blood pressure ≥ 160 mmHg or - diastolic blood pressure ≥ 110 mmHg or heart rate ≥ 110 bpm
- •Continuous opioid medication for more than 2 weeks within half a year before surgery
- •Known allergy or hypersensitivity to tegileridine or any study medication components
- •History of psychiatric illness or inability to communicate effectively
研究组 & 干预措施
Single Group (All Adult Patients Aged ≥18 Years)
All enrolled adult patients aged ≥18 years receive intravenous tegileridine followed by fixed-dose propofol 2 mg/kg for anesthesia induction. This single-group biased-coin sequential up-and-down design starts with an initial tegileridine dose of 10 μg/kg, with 1 μg/kg dose step for increment or decrement based on laryngeal mask airway insertion response. Patients are stratified into young subgroup (18-64 years) and elderly subgroup (≥65 years) for separate ED90 calculation. Intraoperative anesthesia maintenance and perioperative supportive treatments are consistent for all subjects.
干预措施: Tegileridine combined with Propofol for anesthesia induction (Drug)
结局指标
主要结局
90% Effective Dose (ED90) of Tegileridine for Suppressing Laryngeal Mask Airway Insertion Response
时间窗: Within 3 minutes after laryngeal mask airway insertion
The 90% effective dose of intravenous tegileridine combined with fixed-dose propofol to completely inhibit positive responses during laryngeal mask airway insertion, calculated via central ordinal regression with 95% confidence interval. Positive response is defined as any body movement, frowning, tearing, cough, or blood pressure/heart rate increase over 20% compared with baseline within 3 minutes after LMA placement.
次要结局
- Incidence of cough during laryngeal mask airway insertion(From the start of anesthesia induction to the end of anesthesia induction .)
- Success rate of sedation(From the start of intubation to 3 minutes after the end of laryngeal mask airway insertion)
研究者
Shiyou Wei
Department of Anesthesiology
Shanghai Pulmonary Hospital, Shanghai, China