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Trial Title:
Investigating the Optimal Remifentanil and Dexmedetomidine Concentration for Uterine Fibroid Ablation
NCT ID:
NCT06640738
Condition:
Uterine Fibroids (UF)
Conditions: Official terms:
Leiomyoma
Myofibroma
Remifentanil
Conditions: Keywords:
Uterine Fibroids (UF)
Remifentanil
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
arm 2
Description:
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 group label:
arm 2
Other name:
ALVOGEN
Other name:
Remifentanil ALVOGEN®
Intervention type:
Drug
Intervention name:
arm 1
Description:
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 group label:
arm 1
Other name:
Remifentanil ALVOGEN®
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
20 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
October 1, 2024
Completion date:
October 31, 2026
Lead sponsor:
Agency:
Kaohsiung Medical University
Agency class:
Other
Source:
Kaohsiung Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06640738
