Investigating the Optimal Remifentanil and Dexmedetomidine Concentration for Uterine Fibroid Ablation

Phase 4

Not yet recruiting

• Conditions: Uterine Fibroids (UF)
• Interventions: Drug: arm 1; Drug: arm 2

• Registration Number: NCT06640738
• Lead Sponsor: Kaohsiung Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-27
• Status Verified: 2024-10
• Study Start: 2024-10-01
• Study First Submitted QC: 2024-10-11
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Primary Completion: 2026-10-31
• Study Completion: 2026-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arm 1	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.
arm 2	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.