Investigating the Optimal Remifentanil and Dexmedetomidine Concentration for Uterine Fibroid Ablation

October 11, 2024 updated by: Tzu Ying Li, Kaohsiung Medical University

Remifentanil and Dexmedetomidine in Uterine Fibroid Ablation: a Comparative Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ying Tzu Li, Master's degree
  • Phone Number: 7035 886-7-3121101
  • Email: irb-app@kmuh.org.tw

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Remifentanil ALVOGEN®
Active Comparator: 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.
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.
Other Names:
  • ALVOGEN
  • Remifentanil ALVOGEN®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the start of uterine fibroid ablation till 30 minutes after the ablation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the start of uterine fibroid ablation till 30 minutes after the ablation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMUHIRB-F(I)-20240227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

Beginning 3 months and ending 3 years after the publication of results

IPD Sharing Access Criteria

Researchers with a data sharing agreement may be able to share statistical Analysis Plan.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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