Actively Recruiting

Phase 4
Age: 19Years +
All Genders
ID06330038

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

Led by Samsung Medical Center · Updated on 2026-04-20

5384

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

Samsung Medical Center

Lead Sponsor

S

Seoul National University Hospital

Collaborating Sponsor

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 anesthesiologist's 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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 19 years or older
  • 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)
Not Eligible

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

AI-Screening

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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

Trial Site Locations

Total: 1 location

1

Samsung Medical Center

Seoul, Seoul-teukbyeolsi, South Korea, 06351

Actively Recruiting

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Research Team

J

Jeayoun Kim, MD

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.

Jeayoun Kim, Susie Yoon, In-Kyung Song...

https://pubmed.ncbi.nlm.nih.gov/39039548