Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC
Launched by UNIVERSITY OF CRETE · Dec 10, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new approach to anesthesia for patients undergoing a major lung surgery called lobectomy, specifically for early-stage non-small cell lung cancer (NSCLC). The goal is to see if using an Opioid-Free Anesthesia-Analgesia (OFA-A) strategy, which involves a combination of medications that do not include opioids, can reduce the stress and negative effects on the immune system that often come with surgery. Researchers hope that this method will lead to better pain management, fewer post-operative infections, and overall improved recovery compared to the traditional approach that uses opioids.
To participate in this trial, individuals must be between the ages of 65 and 74 and scheduled for an elective VATS lobectomy for early-stage NSCLC. However, certain health conditions, such as being immunocompromised, having uncontrolled diabetes, or a history of lung surgery, may exclude a patient from participating. Participants in the study can expect to receive either the new opioid-free approach or the standard opioid-based anesthesia during their surgery, and they will be monitored for outcomes like pain levels and recovery experiences. This trial is currently recruiting patients, and it aims to improve surgical care for those with lung cancer.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • patients undergoing elective VATS lobectomy
- • early stage NSCLC (up to T3N1M0)
- Exclusion Criteria:
- • Immunocompromised patients
- • previous lung surgery
- • preoperative corticosteroid or immunosuppressive drug use
- • uncontrolled Diabetes Mellitus
- • cardiac failure (NYHA 3 and 4)
- • preoperative infection (CRP \>5mg/ml, WBC \>10x10\^9/L)
- • preoperative anemia (Hb\<12g/dl)
- • chronic inflammatory diseases
- • inflammatory bowel disease
- Group-specific exclusion criteria:
- • OFA-Α: perioperative opioid administration, within the study period
- • OBA-Α: perioperative dexmedetomidine or lidocaine infusion, ketamine, gabapentinoid or corticosteroid administration within the study period
About University Of Crete
The University of Crete is a prominent academic institution dedicated to advancing medical research and education. With a strong emphasis on interdisciplinary collaboration, the university conducts innovative clinical trials aimed at addressing critical health challenges. Its research initiatives are bolstered by a team of experienced faculty and researchers, who are committed to translating scientific discoveries into effective healthcare solutions. The University of Crete's state-of-the-art facilities and commitment to ethical standards ensure that clinical trials are conducted with the highest level of integrity and rigor, contributing to the global body of medical knowledge and improving patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Heraklion, Crete, Greece
Patients applied
Trial Officials
Vasileia Nyktari, MD, PhD
Study Chair
University of Crete, Medical school
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials