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

Study Overview
=================
Brief Summary
-----------------
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. 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.

Detailed Description
-----------------
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, 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 scoress, tumor marker , tumor size, intraoperative blood loss/transfusion, duration of surgery, duration of anesthesia, total opioid (remifentanil/ fentanyl/ propofol) use, postoperative radiation therapy, postoperative chemotherapy, postoperative concurrent chemoradiotherapy, the presence of disease progression, and 6-month, 1-year, and 3-year overall survival and Karnofsky performance status score were recorded.

Official Title
-----------------
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

Conditions
-----------------
Lung Cancer, Brain Tumor, Liver Cancer, Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: Sevoflurane


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevoflurane<br>The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3). | Drug: Sevoflurane<br>* The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC)<br>* Other names: inhalation anesthesia;|
| Experimental: Propofol<br>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. | Drug: Propofol<br>* 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.<br>* Other names: total intravenous anesthesia;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | 6-month overall survival, 1-year overall survival, and 3-year overall survival | From the date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | 
| The presence of disease progression | From the date of surgery until the date of first documented progression (recurrence or metastasis) or date of death from any cause, assessed up to 36 months | From the date of surgery until the date of first documented progression (recurrence or metastasis),assessed up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Clavien-Dindo classification, and other postoperative complications | The period from the day of surgery to postoperative 30 days | 
| Karnofsky performance status score | Karnofsky performance score, from 100 to 0, where 100 is perfect health and 0 is death. The lower the Karnofsky performance score, the worse the likelihood of survival. | postoperation 6 months, postoperation 12 months,postoperation 36 months. | 
| Length of hospital stays | the length of stays in general ward and ICU | from the day of surgery to dischage, assessed up to 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Propofol, Sevoflurane, Survival