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Recruiting Phase 4 NCT05926336

NCT05926336 The Effects of Using Different Anesthetics on the Prognosis of Primary Tumors and Its Mechanism of Action

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Clinical Trial Summary
NCT ID NCT05926336
Status Recruiting
Phase Phase 4
Sponsor Kaohsiung Medical University Chung-Ho Memorial Hospital
Condition Lung Cancer
Study Type INTERVENTIONAL
Enrollment 1,316 participants
Start Date 2023-05-23
Primary Completion 2026-07

Trial Parameters

Condition Lung Cancer
Sponsor Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 1,316
Sex ALL
Min Age 20 Years
Max Age 80 Years
Start Date 2023-05-23
Completion 2026-07
Interventions
PropofolSevoflurane

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Brief Summary

1. Eligible participants were assessed prior to anesthesia. After the patient is admitted to the hospital, the subject's consent form is explained, and the consent form must be signed before the operation. 2. This is a two-arm, parallel-group randomized clinical trial.In the preoperative waiting area, the patients are randomly assigned and divided into two groups according to the allocation sequence table (corresponding to 1:1 randomization) generated by the computer. The propofol group was both induced and maintained at an effect-site concentration (Ce) of 2.0-4.0 mcg/mL by a target-controlled infusion (TCI) system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3). During the operation, the dose of anesthetic drugs (propofol/fentanyl /remifentanil and sevoflurane/cisatracurium/rocuronium) are adjusted to maintain the mean arterial pressure and heartbeat fluctuations within 20% of the baseline value and Entropy (or BIS) value at 40-60in both groups. The following patient data were recorded, the type of anesthesia, sex, age at the time of surgery, preoperative Karnofsky performance status (KPS) score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), ASA physical status scores, tumor marker ,tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/fentanyl) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, 3-year and 5-year overall survival and Karnofsky performance status score were recorded.

Eligibility Criteria

Inclusion Criteria: * eighteen to eighty-year-old * ASA class I-III patients * Elective surgery for brain, liver, lungs, ovarian cancer under general anesthesia Exclusion Criteria: * Severe mental disorder, poor liver function, pregnant or lactating women, morbidly obese, allergy to any of the drugs used in this study, recurrent tumor or repeat surgery, biopsy cases, incomplete outcome-data, palliative treatment after surgery, simultaneous treatment of other malignancies, emergency surgery, presence of other malignant tumors, combined propofol and inhalation anesthesia or other anesthetics, such as ketamine or dexmedetomidine, diagnosed as benign brain, liver, lungs, ovarian cancer、cell carcinoma or other metastatic.

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