Investigating the Optimal Remifentanil and Dexmedetomidine Concentration for Uterine Fibroid Ablation

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age20-65
SponsorKaohsiung Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged between 20 and 65 years old

American Society of Anesthesiology classification I~III

Female patients diagnosed with uterine fibroids by obstetricians and gynecologists

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: arm 1Experimental treatment 1 intervention
Group B: arm 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
From the start of uterine fibroid ablation till 30 minutes after the ablation.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: