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Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation
Sponsor: The First Affiliated Hospital of Xiamen University
Summary
Effective pain management during percutaneous thermal ablation of liver tumors outside the operating room remains a significant challenge. While hepatic hilar nerve block (HHNB) provides partial analgesia, its incomplete efficacy often requires opioid supplementation, potentially increasing perioperative risks. Esketamine, an N-methyl-D-aspartate receptor antagonist, exhibits unique dual analgesic-sedative properties that may address this therapeutic gap, thus obviating the necessity for opioids. This prospective dose-finding study aimed to establish the median effective dose (ED50) and 95% effective dose (ED95) of esketamine for opioid-free analgesia during ultrasound-guided thermal ablation of liver tumors under HHNB. Afterwards, the investigators will conduct an RCT study to evaluate the safety of the dose of esketamine ED95 through the incidence of respiratory depression.
Official title: Study on the Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation Under Hilar Nerve Blockade
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
79
Start Date
2025-06-29
Completion Date
2028-06-30
Last Updated
2025-09-11
Healthy Volunteers
No
Conditions
Interventions
Intravenous esketamine using Dixon's up-and-down sequential method
Using Dixon's up-and-down sequential method, esketamine will be titrated intravenously from an initial 0.3 mg∙kg-1 dose with 0.02 mg∙kg-1 adjustments based on intraprocedural responses to pain (Positive: purposeful somatic movement or the complaint of pain; Negative: no movement or no complaint of pain). The titration sequence will continue until six crossover inflection points are observed.
Intravenous the dose of esketamine ED95
The intervention group will be injected with the dose of esketamine ED95.
Intravenous fentanyl 1 μg∙kg-1
The control group will be injected with fentanyl 1 μg∙kg-1.
Locations (1)
Department of Anesthesiology, The First Affiliated Hospital of Xiamen University, 55 Zhenhai Road, Xiamen, China
Xiamen, Fujian, China