Investigating the Optimal Remifentanil and Dexmedetomidine Concentration for Uterine Fibroid Ablation

NCT06640738 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: KMUHIRB-F(I)-20240227
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Uterine Fibroids (UF)

Keywords

Uterine Fibroids (UF); Remifentanil

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Vital signs during uterine fibroid ablation

  From the start of uterine fibroid ablation till 30 minutes after the ablation.

Study Arms (2)

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.

Drug: arm 1

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.

Drug: arm 2

Interventions

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.

Also known as: ALVOGEN, Remifentanil ALVOGEN®

arm 2

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.

Also known as: Remifentanil ALVOGEN®

arm 1

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 20 and 65 years old
• American Society of Anesthesiology classification I\~III
• Female patients diagnosed with uterine fibroids by obstetricians and gynecologists

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University: lead

MeSH Terms

Conditions

Leiomyoma

Interventions

DMAC2L protein, human

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Ying Tzu Li, Master's degree

CONTACT

886-7-3121101; irb-app@kmuh.org.tw

Kuang I Cheng, Doctor of Philosophy Ph.D.

CONTACT

886-7-3121101; trustwithtrust@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 15, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 3 years after the publication of results
• Access Criteria: Researchers with a data sharing agreement may be able to share statistical Analysis Plan.