Investigating the Optimal Remifentanil and Dexmedetomidine Concentration for Uterine Fibroid Ablation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: arm 2, arm 1.
- Who it may be relevant to
- Registry conditions: Uterine Fibroids (UF). Basic parameters: 20 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Remifentanil and Dexmedetomidine in Uterine Fibroid Ablation: a Comparative Study
Overview
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
- Drug arm 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. - Drug arm 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.
Primary outcome measures
- Pain scores during uterine fibroid ablation [Time frame: From the start of uterine fibroid ablation till 30 minutes after the ablation.]
Secondary outcome measures (1)
- Vital signs during uterine fibroid ablation [Time frame: From the start of uterine fibroid ablation till 30 minutes after the ablation.]
Eligibility criteria
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06640738 · KMUHIRB-F(I)-20240227