drugset / Trial / NCT07034950

Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation

NCT07034950

Phase 1/2 Active not recruiting 79 enrolled The First Affiliated Hospital of Xiamen University
RandomizedSequentialQuadruple-blindSupportive care

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.

Timeline

Start
2025-06-29
Primary completion
2028-06-30
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Esketamine Other / unclassified 0.3 mg/kg Intravenous
Comparator Fentanyl Other / unclassified 1 ug/kg Intravenous

Indications