Investigating the Optimal Remifentanil and Dexmedetomidine Concentration for Uterine Fibroid Ablation
NCT ID: NCT06640738
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
60 participants
INTERVENTIONAL
2024-10-01
2026-10-31
Brief Summary
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\[primary hypothesis 1\] 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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 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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiology classification I\~III
* Female patients diagnosed with uterine fibroids by obstetricians and gynecologists
Exclusion Criteria
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
20 Years
65 Years
FEMALE
No
Sponsors
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Kaohsiung Medical University
OTHER
Responsible Party
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Tzu Ying Li
Attending Physician
Central Contacts
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Other Identifiers
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KMUHIRB-F(I)-20240227
Identifier Type: -
Identifier Source: org_study_id
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