NCT05663242

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DRUG	Sevoflurane	The sevoflurane group was maintained via sevoflurane vaporizer between 1% and 3% (target minimum alveolar concentration of 0.7-1.3 MAC)

Timeline

• Start date: 2022-12-27
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2022-12-23
• Last updated: 2023-05-30

Locations

1 site across 1 country: Taiwan