Clinical trial · Interventional
Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation
Study on the Effective Dose and Safety of Esketamine During Ultrasound-guided Hepatic Tumor Thermal Ablation Under Hilar Nerve Blockade
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Cancer | — | UNRESOLVED | — |
| Hepatic Neoplasm | Liver Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous esketamine using Dixon's up-and-down sequential method | Drug | — | UNRESOLVED |
| Intravenous fentanyl 1 μg∙kg-1 | Drug | — | UNRESOLVED |
| Intravenous the dose of esketamine ED95 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Determine the ED50 and ED95 of esketamine by Dixon's up-and-down method
- description
- 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). All patients will receive standardized premedication with HHNB. The titration sequence will continue until six crossover inflection points are observed.
- interventionNames
- Drug: Intravenous esketamine using Dixon's up-and-down sequential method
- type
- ACTIVE_COMPARATOR
- label
- Evaluate the safety of the dose of esketamine ED95 by the incidence of respiratory depression
- description
- The intervention group will be injected with the dose of esketamine ED95; the control group will be injected with fentanyl 1 μg∙kg-1. The study at this stage will evaluate the safety of the dose of esketamine ED95 through the incidence of respiratory depression.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 18 - 80 years; * ASA physical status Ⅰ or Ⅲ; * Body mass index (BMI) 18 - 28 kg∙m-2; * Scheduled for elective ultrasound-guided thermal ablation of solitary liver tumors under HHNB. Exclusion Criteria: (i) Pharmacological contraindications: * Known hypersensitivity to study medications (esketamine, midazolam); * Opioid or benzodiazepine dependence; * Using analgesics within the last 24 h preoperatively; * Participation in other investigational drug trials within 90 days. (ii) Clinical comorbidities and surgery history: * Multifocal hepatic lesions requiring concurrent ablation; * Patients after liver transplantation; * Active upper respiratory tract infection within 14 days; * Severe cardiopulmonary diseases (New York Heart Association \[NYHA\] class Ⅲ-Ⅳ, FEV1/FVC \< 70%); * Decompensated hepatic insufficiency (Child-Pugh C); * Uncontrolled hypertension (≥180/110 mmHg), elevated intracranial/intraocular pressure, or hyperthyroidism; * Major neuropsychiatric disorders (epilepsy, schizophrenia, major depressive disorder, cognitive impairment). (iii) Procedural Risk Factors: * Anticipated difficult airway (Mallampati Ⅲ-Ⅳ, thyromental distance \< 6 cm) or anatomical airway obstruction; * Inadequate preoperative fasting (solid intake \< 8 hours, clear fluids \< 2 hours).
References
Publications (0)
Data not yet available