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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm 1 | Experimental | 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. |
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| arm 2 | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arm 2 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores during uterine fibroid 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. | From the start of uterine fibroid ablation till 30 minutes after the ablation. |
| Measure | Description | Time Frame |
|---|---|---|
| Vital signs during uterine fibroid 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. | From the start of uterine fibroid ablation till 30 minutes after the ablation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Tzu Li, Master's degree | Contact | 886-7-3121101 | 7035 | irb-app@kmuh.org.tw |
| Kuang I Cheng, Doctor of Philosophy Ph.D. | Contact | 886-7-3121101 | 7184 | trustwithtrust@gmail.com |
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all IPD that underlie results in a publication
Beginning 3 months and ending 3 years after the publication of results
Researchers with a data sharing agreement may be able to share statistical Analysis Plan.
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000608097 | DMAC2L protein, human |
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| arm 1 | Drug | 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. |
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