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NOT YET RECRUITING
NCT06640738
PHASE4

Investigating the Optimal Remifentanil and Dexmedetomidine Concentration for Uterine Fibroid Ablation

Sponsor: Kaohsiung Medical University

View on ClinicalTrials.gov

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.

Official title: Remifentanil and Dexmedetomidine in Uterine Fibroid Ablation: a Comparative Study

Key Details

Gender

FEMALE

Age Range

20 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-10-01

Completion Date

2026-10-31

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

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.

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.