Investigating the Optimal Remifentanil and Dexmedetomidine Concentration for Uterine Fibroid Ablation

Kaohsiung Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Uterine Fibroids (UF)

Treatments: Drug: arm 1; Drug: arm 2

Study type: Interventional

Funder types: Other

Identifiers

NCT06640738

KMUHIRB-F(I)-20240227

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

arm 1

Experimental group

Description:

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.

Treatment:

Drug: arm 1

arm 2

Active Comparator group

Description:

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.

Treatment:

Drug: arm 2