Esophageal mucosal lesions: early esophageal cancer, high-grade intraepithelial neoplasia
Conditions
Interventions
Experimental Group(Dexmedetomidine Combined with Oxycodone Group): Dexmedetomidine combined with oxycodone regimen
Control Group( Oxycodone Monotherapy Group): Oxycodone monotherapy regimen
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years, diagnosed with esophageal or gastric mucosal lesions (e.g., early cancer, high-grade intraepithelial neoplasia) by endoscopy and pathology, and meeting the indications for endoscopic submucosal dissection (ESD); 2. The patient or their legal representative must fully understand the purpose, methods, risks, benefits and other relevant information of the study, and voluntarily sign the informed consent form; 3. American Society of Anesthesiologists (ASA) physical status classification ?–?, without severe cardiopulmonary dysfunction; 4.No history of long-term use of opioids or sedatives, and no history of drug dependence; 5.No known allergies or contraindications to the drugs used in the study, such as dexmedetomidine and oxycodone.
Exclusion criteria
Exclusion criteria: 1. The subject or their family members refuse to participate in the clinical study; 2. Preoperative comorbidity with severe uncontrolled underlying diseases, such as: severe cardiopulmonary diseases (NYHA cardiac function class >=?, COPD GOLD stage >=3), abnormal liver or kidney function (ALT/AST > 2 times the upper limit of normal, Cr > 1.5 times the upper limit of normal), uncontrolled hypertension (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg) or diabetes mellitus (fasting blood glucose > 11.1 mmol/L); 3. Severe mental illness or communication disorders that prevent cooperation with study assessments; 4. Known allergies to dexmedetomidine, oxycodone, or other drugs involved in the study; 5. Long-term use of analgesics, antidepressants, sedatives, or hormonal drugs; 6. Patients with coagulation disorders or bleeding tendencies; 7. Pregnant or lactating women; 8. Preoperative infectious diseases (e.g., fever, infectious foci) or distant tumor metastasis; 9. Severe intraoperative complications of ESD (e.g., perforation, massive hemorrhage requiring conversion to open surgery).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour Postoperative Resting Pain Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Resting / cough vas dynamic score;Incidence of moderate to severe postoperative pain (VAS score > 3);Rescue analgesia rate;Incidence of intraoperative cardiovascular events;Incidence of postoperative nausea and vomiting (PONV); | — |
Countries
China
Contacts
Public ContactZhang Jinwei
Nanjing Drum Tower Hospital
Outcome results
None listed