NCT07034950Active, not recruitingPhase 1/2
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 · Last updated 11 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 79 (estimated)
- First submitted
- 29 May 2025
- Start date
- Jun 2025
- Primary completion date
- Jun 2028
- Lead sponsor
- The First Affiliated Hospital of Xiamen University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07034950
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 79
- From Jun 2025 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- Known hypersensitivity to study medications (esketamine, midazolam);
- 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:
Other
- (i) Pharmacological contraindications:
- Opioid or benzodiazepine dependence;
- Using analgesics within the last 24 h preoperatively;
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Anesthesiology, The First Affiliated Hospital of Xiamen University, 55 Zhenhai Road, Xiamen, China Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.