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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05926336
• Other study ID #: KMUHIRB-F(I)-20230075
• Status: Recruiting
• Phase: Phase 4
• Start date: May 23, 2023
• Est. completion date: July 2026

Study information

• Verified date: May 2023
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Zhi-Fu Wu, MD
• Phone: 07-3121101
• Email: aneswu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1316
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Tumor
• Carcinoma, Ovarian Epithelial
• Liver Cancer
• Lung Cancer
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Propofol
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.
• Sevoflurane
The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC)

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	time of operation and anesthesia	record the time the opeartion and anesthesia	from start to end of the procedure
Other	blood loss	record the blood loss (ml)	from start to end of the procedure
Other	volume of blood transfusion	volume of blood transfusion (ml)	from start to end of the procedure
Primary	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
Primary	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	Postoperative complications	Clavien-Dindo classification, and other postoperative complications	The period from the day of surgery to postoperative 30 days
Secondary	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.
Secondary	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