Phase I Trial of Emulsified Isoflurane in Adult Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Vital Signs
研究概览
简要总结
In this trial, our primary goal is to investigate the safety of intravenous infusion of emulsified isoflurane. In order to protect volunteers, the investigators adopt the modified Fibonacci dose-escalation, starting from a very low dose which is derived from the 1/600 of acute LD50 in pre-clinic study. The trial will be terminated if half of volunteers develop severe adverse event in any dose group or any volunteer develop fatal adverse event in any group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18~45 years old (50:50 male:female) healthy volunteer;
- •Body Mass Index (BMI) 19~24;
- •health volunteers assessed by medical history and physical examination
- •systolic blood pressure between 100~140mmHg;
- •heart rate between 60~100bpm;
- •pulse oxygen saturation > 97% when inspiring air and reaching 100% after inspiring 100% oxygen for 5 min;
- •with normal result for routine lab test, including complete blood count, chemical test, urine test and stool test;
- •Non-smoker and no history of alcohol or drug abuse;
- •Fully understand the whole process of this trial and sign the informed consent.
排除标准
- •Any history of allergy, especially to isoflurane or intralipid;
- •Any suspected history of malignant hyperthermia in the volunteer or his/her relatives;
- •Recent use of a medication with a pronounced effect on the central nervous system or any other organ (within 3 month)
- •Recent participation in other clinical trial (within 1 month)
- •Any history of difficult airway or suspected difficult airway;
- •Pregnancy;
- •Hyperlipidemia.
研究组 & 干预措施
Arm 1 (0.0024 ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0024ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 2 (0.006ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.006ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 3 (0.012ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.012ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 4 (0.02ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.02ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 5 (0.0301ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0301ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 6 (0.0391ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0391ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 7 (0.0508ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0508ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 8 (0.066ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.066ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 9 (0.0859ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.0859ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 10 (0.1116ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1116ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 11 (0.1451ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1451ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 12 (0.1886ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.1886ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 13 (0.2452ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.2452ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 14 (0.3188ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.3188ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 15 (0.4144ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.4144ml/kg.
干预措施: Emulsified Isoflurane (Drug)
Arm 16 (0.5387ml/kg)
In this group, the volunteers receive emulsified isoflurane (120mg/ml) at the dose of 0.5387ml/kg.
干预措施: Emulsified Isoflurane (Drug)
结局指标
主要结局
Vital Signs
时间窗: after drug infusion to 24 hours after infusion
The vital signs include heart rate, cardiac rhythm, blood pressure, respiratory rate, pulse oxygen saturation, body temperature and end-tidal carbon dioxide. All the parameters are measured at the following time points: 1. before drug infusion, recorded as baseline; 2. every one minute, immediately from drug infusion to 15 min after infusion; 3. every two minutes, from 15 min to 30 min after infusion; 4. every five minutes, from 30 min to 60 min afeter infusion; 5. every one hour, from 1 hour to 4 hours after infusion; 6. 8 hours and 24 hours after infusion.
次要结局
- Efficacy of emulsified isoflurane as an intravenous anesthetics(immediate from drug infusion, up to 24 hours after infusion)