Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT07034950
Eligibility Criteria:
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07034950
Study Brief:
Protocol Section:
NCT07034950