Uterine Fibroids (UF)
Conditions
Keywords
Uterine Fibroids (UF), Remifentanil
Brief summary
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.
Interventions
DRUGarm 2
This study tries to find the best drug concentration of Remifentanil, ALVOGEN® (2 mg/vial) in Uterine Fibroid Ablation. We have two arms. Arm 1 with Remifentanil, ALVOGEN® (2 mg/vial) 1.0 ng/mL, and arm 2 with Remifentanil, ALVOGEN® (2 mg/vial) 2.0 ng/mL, both given via a syringe infusion pump, Perfusor® Space \| B. Braun.
DRUGarm 1
This study tries to find the best drug concentration of Remifentanil, ALVOGEN® (2 mg/vial) in Uterine Fibroid Ablation. We have two arms. Arm 1 with Remifentanil, ALVOGEN® (2 mg/vial) 1.0 ng/mL, and arm 2 with Remifentanil, ALVOGEN® (2 mg/vial) 2.0 ng/mL, both given via a syringe infusion pump, Perfusor® Space \| B. Braun.
Sponsors
Kaohsiung Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 20 and 65 years old * American Society of Anesthesiology classification I\ III * Female patients diagnosed with uterine fibroids by obstetricians and gynecologists
Exclusion criteria
1. Patients with heart disease (such as arrhythmia or severe ventricular dysfunction) 2. Patients with chronic kidney disease in stage III or above or dialysis patients 3. Long-term alcohol addiction or drug abuse 4. Patients with abnormal liver index or chronic hepatitis 5. Those who are allergic Remifentanil 6. Those who refuse to participate in the experiment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores during uterine fibroid ablation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vital signs during uterine fibroid ablation | 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. Vital signs (including blood pressure, oxygen saturation and heart rates) will be recorded during uterine fibroid ablation. |
Contacts
Primary ContactYing Tzu Li, Master's degree
Backup ContactKuang I Cheng, Doctor of Philosophy Ph.D.
Outcome results
None listed