Effect of Propofol Versus Inhaled Anesthesia on Recurrence-Free Survival After Lung Cancer Surgery in Adults
Led by Samsung Medical Center · Updated on 2026-04-20
5384
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying patients with non-small cell lung cancer NSCLC to compare the effects of two types of anesthesia on cancer recurrence after surgery. The trial aims to test whether patients who receive total intravenous anesthesia TIVA with propofol have a higher recurrence-free survival compared to those who receive volatile inhaled anesthetics. This is a multicenter, randomized, double-blind phase 4 trial involving 22 international sites and adult patients undergoing lung resection surgery with curative intent for NSCLC.
Participants will be randomly assigned to one of two groups the TIVA group, which receives propofol for induction and maintenance of general anesthesia, or the GAS group, which receives one or more volatile anesthetics such as sevoflurane, desflurane, or isoflurane for anesthesia. In the GAS group, additional co-induction agents like propofol or midazolam may be used at the anesthesiologists discretion. The trial does not standardize other aspects of patient care but balances potential confounders between groups.
During the study, participants will be followed for outcomes including recurrence-free survival within 3 years after surgery, overall survival, and complications occurring within 7 days post-surgery or earlier at discharge. Data will be collected through a secure web-based system, and enrollment of 5,384 patients is planned to provide sufficient power for detecting differences in outcomes. The trial is expected to end by the end of 2028, with safety and effectiveness monitored throughout the study period.
CONDITIONS
Brief Title
Anesthesia and Non-small Cell Lung Cancer Recurrence
Research Team
J
Jeayoun Kim, MD
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American Society of Anesthesiologists physical status (ASA) I to III
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
Undergoing lung resection surgery (segmentectomy, lobectomy, bilobectomy, pneumonectomy; video-assisted, robot-assisted, or open) with curative intent for NSCLC (clinical Tumor, Node, Metastasis (TNM) stage I to IIA)
You will not qualify if you...
Presence of distant metastasis or malignant tumor in other organs not in long-term remission
Severe neurological conditions
Severe hepatic disease classified as Child-Pugh C
Renal failure requiring renal replacement therapy
History of anesthesia or surgery within the past 1 year
Previous lung cancer surgery except diagnostic biopsies
Contraindications to any study medication including allergy or hypersensitivity
Planned joint extrapulmonary procedure
Surgery under cardiopulmonary bypass or extracorporeal membrane oxygenation
Postoperative sedation
Pregnancy or lactation
Patient refusal
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - Day of surgery
Participants undergo lung resection surgery with either propofol-based total intravenous anesthesia (TIVA) or inhaled anesthetics for anesthesia during surgery.
1 visit (in-person)
Post-operative Follow-up
Duration - Up to 7 days post-surgery
Participants are monitored for complications within 7 days after surgery or until discharge if earlier.
Approximately 1 to 2 visits (in-person)
Long-term Monitoring
Duration - Up to 3 years
Participants are followed for recurrence free survival and overall survival for up to 3 years after surgery.
Periodic visits as scheduled by the study site
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Recurrence-free survival after curative resection of non-small cell lung cancer between inhalational gas anesthesia and propofol-based total intravenous anesthesia: a multicenter, randomized, clinical trial (GAS TIVA trial): protocol description.