RecruitingPhase 4NCT05926336

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

To Compare the Effects of Intraoperative Use of Intravenous Anesthetics Propofol and Inhaled Anesthetics Sevoflurane on the Prognosis of Patients Undergoing Surgery for Primary Brain, Liver, Lung, and Ovarian Cancer Tumors and the Investigation of Its Mechanism of Action


Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Enrollment

1,316 participants

Start Date

May 23, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 YearsMax Age: 80 Years

Inclusion Criteria3

  • eighteen to eighty-year-old
  • ASA class I-III patients
  • Elective surgery for brain, liver, lungs, ovarian cancer under general anesthesia

Exclusion Criteria1

  • 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.

Interventions

DRUGPropofol

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.

DRUGSevoflurane

The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC)


Locations(1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

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NCT05926336


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