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

NCT ID: NCT05663242

Last Updated: 2023-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-27
• Study Completion Date: 2026-11-30

Brief Summary

This is a two-arm, parallel-group randomized clinical trial. Routine perioperative care would be performed in volunteers with primary early lung cancer. The study will enroll approximately 300 volunteers to compare the progression-free or overall survival in patients undergoing video-assisted thoracoscopic surgery (VATS) for primary lung tumors between propofol and sevoflurane for the maintenance of anesthesia.

Detailed Description

Before the scheduled procedure, the patients are randomly assigned into peopofol group or groups (1:1) according to the randomization generated by the computer. Both groups were induced with propofol 1~2.5 mg/kg propofol. The propofol group was maintained at an effect-site concentration of 2.0-4.0 mcg/mL by a target-controlled infusion system. The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC). 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 score and functional capacity, the postoperative complications within 30 days (according Clavien-Dindo classification), American Society of Anesthesiologists physical status scores, 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.

Conditions

Lung Cancer; Progression, Disease; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sevoflurane

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

Group Type: EXPERIMENTAL

Sevoflurane

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Sevoflurane

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

Intervention Type: DRUG

Other Intervention Names

total intravenous anesthesia; inhalation anesthesia

Eligibility Criteria

Inclusion Criteria

• eighteen to eighty-year-old
• ASA class I-III patients
• Received elective thoracic surgery for primary lung tumors under general anesthesia

Exclusion Criteria

• 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 lung tumor, or other metastatic lung tumor

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Hung-Te Hsu, MD

Role: CONTACT

hdhsu1228@hotmail.com

07-3121101 ext. 7035

Facility Contacts

Hung-Te Hsu

Role: primary

Other Identifiers

KMUHIRB-F(I)-20210218.

Identifier Type: -

Identifier Source: org_study_id