Remifentanil and Dexmedetomidine in Uterine Fibroid Ablation: a Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Pain scores during uterine fibroid ablation
研究概览
简要总结
This clinical trial aims to find a better drug concentration of Remifentanil in Uterine Fibroid Ablation. The main question it seeks to answer is:
[primary hypothesis 1] Remifentanil concentration of 2.0 ng/mL provides better pain control in Uterine Fibroid Ablation.
There is a comparison group in this study: Researchers will compare Remifentanil concentration of 1.0 ng/mL to see if provides similar pain control with fewer side effects.
Participants will be separated into two groups, one group with a Remifentanil concentration of 2.0 ng/mL and the other 1.0 ng/mL. During uterine fibroid ablation, the patient's pain index will be recorded (using a Visual Analogue Scale (VAS) of 0~10 points). We will also record vital signs during the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged between 20 and 65 years old
- •American Society of Anesthesiology classification I~III
- •Female patients diagnosed with uterine fibroids by obstetricians and gynecologists
排除标准
- •Patients with heart disease (such as arrhythmia or severe ventricular dysfunction)
- •Patients with chronic kidney disease in stage III or above or dialysis patients
- •Long-term alcohol addiction or drug abuse
- •Patients with abnormal liver index or chronic hepatitis
- •Those who are allergic Remifentanil
- •Those who refuse to participate in the experiment
研究组 & 干预措施
arm 1
During uterine fibroid ablation, the arm1 participant received Remifentanil [ ALVOGEN® (2 mg/vial)] 1.0 ng/mL via syringe infusion pump [Perfusor® Space | B. Braun] as a pain treatment.
干预措施: arm 1 (Drug)
arm 2
During uterine fibroid ablation, the arm2 participant received Remifentanil [ ALVOGEN® (2 mg/vial)] 2.0 ng/mL via syringe infusion pump [Perfusor® Space | B. Braun] as a pain treatment.
干预措施: arm 2 (Drug)
结局指标
主要结局
Pain scores during uterine fibroid ablation
时间窗: From the start of uterine fibroid ablation till 30 minutes after the ablation.
Participants will be separated into 2 groups, one with remifentanil 1.0 ng/mL, and the other with remifentanil 2.0 ng/mL. Pain scores will be recorded during uterine fibroid ablation.
次要结局
- Vital signs during uterine fibroid ablation(From the start of uterine fibroid ablation till 30 minutes after the ablation.)
研究者
Tzu Ying Li
Attending Physician
Kaohsiung Medical University