The Effect of Remifentanil on ED95 of Remimazolam for Loss of Consciousness in Adult Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Remimazolam dose at which loss of consciousness occurs
研究概览
简要总结
This study prospectively uses the biased coin technique to investigate the effect of concomitant administration of remifentanil on the 95% effective dose of intravenous remimazolam (Effective dose 95 [ED95]) required for loss of consciousness during anesthesia induction. .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The adult patients who are scheduled to surgery under general anesthesia
排除标准
- •Severe obesity (BMI > 30 kg/m2)
- •Allergy to remimazolam or remifentanil
- •Under conditions which make it difficult to respond to the investigator's verbal commends like hearing impairment, etc.
- •Patients with general conditions are more than ASA class III
- •Patients with brain disease (dementia, cerebral infarction, etc.)
研究组 & 干预措施
remifentanil group
Start the continuous infusion of 25cc of remifantanil (labeled as a test drug) by TCI mode ( the target effect site concentration is 2.0).
While slowly injecting the prescribed dose of remimazolam over 30 seconds, observe whether it responds to the investigator's oral commands and the disappearance of the eyelash reflex for 3 minutes after administering the drug. Success in inducing loss of consciousness during anesthesia is defined as the loss of both verbal command response and eyelash reflex within 3 minutes after infusion, otherwise it is considered a failure.
The dose of remimazolam is initially 0.15 mg/kg and the next experimental dose is determined according to the biased coin design up-and-down sequential method. The standard deviation of this study is 0.05 mg.
干预措施: Remimazolam (Drug)
remifentanil group
Start the continuous infusion of 25cc of remifantanil (labeled as a test drug) by TCI mode ( the target effect site concentration is 2.0).
While slowly injecting the prescribed dose of remimazolam over 30 seconds, observe whether it responds to the investigator's oral commands and the disappearance of the eyelash reflex for 3 minutes after administering the drug. Success in inducing loss of consciousness during anesthesia is defined as the loss of both verbal command response and eyelash reflex within 3 minutes after infusion, otherwise it is considered a failure.
The dose of remimazolam is initially 0.15 mg/kg and the next experimental dose is determined according to the biased coin design up-and-down sequential method. The standard deviation of this study is 0.05 mg.
干预措施: remifantanil (Drug)
control group
Start the continuous infusion of 25cc of normal saline (labeled as a test drug).
While slowly injecting the prescribed dose of remimazolam over 30 seconds, observe whether it responds to the investigator's oral commands and the disappearance of the eyelash reflex for 3 minutes after administering the drug. Success in inducing loss of consciousness during anesthesia is defined as the loss of both verbal command response and eyelash reflex within 3 minutes after infusion, otherwise it is considered a failure.
The dose of remimazolam is initially 0.15 mg/kg and the next experimental dose is determined according to the biased coin design up-and-down sequential method. The standard deviation of this study is 0.05 mg.
干预措施: Remimazolam (Drug)
结局指标
主要结局
Remimazolam dose at which loss of consciousness occurs
时间窗: 3 min after remimazolam injection
While slowly injecting the prescribed dose of remimazolam over 30 seconds, observe whether it responds to the investigator's oral commands and the disappearance of the eyelash reflex for 3 minutes after administering the drug. Success in inducing loss of consciousness during anesthesia is defined as the loss of both verbal command response and eyelash reflex within 3 minutes after infusion, otherwise it is considered a failure.
次要结局
- Time to loss of consciousness(time after injection of remimazolam to loss of conciousness)
研究者
Jiyoung Yoo
associate professor
Ajou University School of Medicine