Uterine Fibroids (UF)Phase 4NCT06640738
Investigating the Optimal Remifentanil and Dexmedetomidine Concentration for Uterine Fibroid Ablation
A Phase 4 study testing arm 2 and arm 1 in people with Uterine Fibroids (UF), run by Kaohsiung Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Uterine Fibroids (UF)
- What is being tested?
- arm 2 and arm 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 31 Oct 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 20 and 65 years old
- American Society of Anesthesiology classification I~III
- Female patients diagnosed with uterine fibroids by obstetricians and gynecologists
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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)
- Being tested
- arm 2, arm 1
- Keywords
- Uterine Fibroids (UF), Remifentanil
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arm 2Drug
Also called ALVOGEN, Remifentanil ALVOGEN®
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.
arm 1Drug
Also called Remifentanil ALVOGEN®
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: arm 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the start of uterine fibroid ablation till 30 minutes after the ablation.
Secondary outcomes (1)
Vital signs 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. Vital signs (including blood pressure, oxygen saturation and heart rates) will be recorded during uterine fibroid ablation.
Measured: From the start of uterine fibroid ablation till 30 minutes after the ablation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Fibroids (UF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tzu Ying Li, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640738
- Sponsor's protocol ID
- KMUHIRB-F(I)-20240227
- Status last verified
- Oct 2024
- First submitted
- 27 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil and Dexmedetomidine in Uterine Fibroid Ablation: a Comparative Study
- ClinicalTrials.gov ID
- NCT06640738
- Acronym / sponsor ID
- KMUHIRB-F(I)-20240227
- Conditions
- Uterine Fibroids (UF)
- Keywords
- Uterine Fibroids (UF), Remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arm 1 | Experimental | Drug: arm 1During 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 | Active comparator | Drug: arm 2During 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 20 and 65 years old
- American Society of Anesthesiology classification I~III
- Female patients diagnosed with uterine fibroids by obstetricians and gynecologists
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arm 2Also: ALVOGEN, Remifentanil ALVOGEN®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. | Drug | arm 2 |
| arm 1Also: Remifentanil ALVOGEN®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. | Drug | arm 1 |
Primary outcome
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.
1 secondary outcome
Vital signs during uterine fibroid ablation
Time frame: From the start of uterine fibroid ablation till 30 minutes after the ablation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing arm 2 and arm 1 in people with Uterine Fibroids (UF), run by Kaohsiung Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying Tzu Li, Master's degree (886-7-3121101 ext. 7035, irb-app@kmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores during uterine fibroid ablation (time frame: From the start of uterine fibroid ablation till 30 minutes after the ablation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.