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NCT Number: NCT06640738

Investigating the Optimal Remifentanil and Dexmedetomidine Concentration for Uterine Fibroid Ablation

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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Key information

Conditions

Uterine Fibroids (UF) Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ALVOGEN, Remifentanil ALVOGEN®

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.

Other names: Remifentanil ALVOGEN®

Primary outcomes

  1. Pain scores during uterine fibroid ablation

    Time frame: 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 outcomes

  1. Vital signs during uterine fibroid ablation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kuang I Cheng, Doctor of Philosophy Ph.D.

CONTACT

[email protected]

886-7-3121101 ext. 7184

Ying Tzu Li, Master's degree

CONTACT

[email protected]

886-7-3121101 ext. 7035

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University

Other

Registry information

Official study title

Remifentanil and Dexmedetomidine in Uterine Fibroid Ablation: a Comparative Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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