Effective Dose of Oliceridine for Inhibiting Hemodynamic Elevation Induced by Tracheal Intubation: An Up-and-Down Sequential Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- ED₉₅ of oliceridine for suppression of tracheal intubation-induced hemodynamic response
研究概览
简要总结
This is a clinical trial using an up-and-down sequential design, aiming to investigate the median effective dose (ED50) and 95% effective dose (ED95) of oliceridine for inhibiting hyperdynamic responses induced by tracheal intubation during general anesthesia induction. The study will enroll patients undergoing elective tracheal intubation under general anesthesia, stratified into young (18-65 years) and elderly (≥65 years) groups. By dynamically adjusting oliceridine doses, the optimal induction dose in different age groups will be evaluated to provide reference for rational clinical medication.
详细描述
- Study Objectives To determine the ED50 and ED95 of oliceridine in inhibiting tracheal intubation-induced hyperdynamic responses (e.g., increased blood pressure and heart rate) during general anesthesia induction, and to provide dose evidence for individualized anesthesia induction protocols.
- Study Design Type: A dynamic dose-finding clinical trial using the modified Dixon up-and-down sequential design.
Sample Size: 35 cases per group anticipated, with trial termination after 7 cross-overs between positive and negative responses (i.e., transitions in whether hemodynamic responses exceed 20% of baseline).
Grouping: Stratified by age into young group (18-65 years) and elderly group (≥65 years). 3. Study Participants
Inclusion Criteria:
Patients undergoing elective tracheal intubation under general anesthesia; Aged ≥18 years; American Society of Anesthesiologists (ASA) physical status Ⅰ-Ⅲ; Body mass index (BMI) < 25.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label study; participants, investigators, and outcome assessors are aware of the intervention assignment.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgery requiring general anesthesia with tracheal intubation
- •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
- •Preoperative long-term use of analgesic or sedative medications
- •Pregnancy, breastfeeding, known or planned pregnancy
- •Known allergy or hypersensitivity to oliceridine or any study medication components
- •History of psychiatric illness or inability to communicate effectively
研究组 & 干预措施
Oliceridine Up-and-Down Sequential Dose-Finding Arm
In this single-group, up-and-down sequential design, adult patients receive a single intravenous bolus of oliceridine.
- Initial dose: 45 µg/kg for ages 18-65 years; 40 µg/kg for ≥ 65 years
- Two minutes later: propofol 2 mg/kg iv
- At loss of consciousness (MOAA/S ≤ 1): rocuronium 0.6 mg/kg iv
- Direct-laryngoscope tracheal intubation performed upon full muscle relaxation
- Hemodynamic variables (BP, HR) recorded at baseline, 2 min post-oliceridine, immediately pre-intubation, and for 3 min post-intubation
- A "positive" response (hemodynamic surge) is defined as ≥ 20% increase in MAP or HR, HR ≥ 120 bpm, or SBP ≥ 180 mmHg
- Next patient's oliceridine dose is adjusted ± 3 µg/kg according to the preceding patient's response
- Sequential dosing continues until seven crossovers are observed, allowing estimation of ED₅₀ and ED₉₅.
干预措施: Oliceridine Injection (Drug)
结局指标
主要结局
ED₉₅ of oliceridine for suppression of tracheal intubation-induced hemodynamic response
时间窗: From the start of intubation to 3 minutes after the end of intubation
95% effective dose (ED₉₅) of oliceridine required to prevent a positive hemodynamic response-defined as ≥ 20% increase in mean arterial pressure or heart rate, heart rate ≥ 120 bpm, or systolic blood pressure ≥ 180 mmHg-within 3 minutes after tracheal intubation during general anesthesia induction, estimated by probit regression analysis of up-and-down sequential dosing data.
ED₅₀ of oliceridine for suppression of tracheal intubation-induced hemodynamic response
时间窗: From the start of intubation to 3 minutes after the end of intubation
Median effective dose (ED₅₀) of oliceridine required to prevent a positive hemodynamic response-defined as ≥ 20% increase in mean arterial pressure or heart rate, heart rate ≥ 120 bpm, or systolic blood pressure ≥ 180 mmHg-within 3 minutes after tracheal intubation during general anesthesia induction, estimated by probit regression analysis of up-and-down sequential dosing data.
次要结局
- The number of cases with coughing(From the start of anesthesia induction to 3 minutes after the end of intubation)
研究者
Shiyou Wei
Department of Anesthesiology
Shanghai Pulmonary Hospital, Shanghai, China