Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study, the investigators intend to select patients with resectable NSCLC treated with immuno-neoadjuvant therapy in combination with chemotherapy, and systematically observe the effect of preoperative anti-PD-1 monotherapy on patients' perioperative pain and opioid analgesia, and evaluate its effect on the incidence and severity of patients' postoperative delirium, in order to provide a clinical basis for the perioperative management of patients treated with immuno-neoadjuvant therapy and promote their postoperative recovery.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborators: Tianjin Chest Hospital; Tianjin Medical University General Hospital

Criteria

Inclusion Criteria:

• Histologically confirmed stage II or stage IIIA non-small cell lung cancer and meet the requirements for R0 resection;

• Has measurable disease assessed according to RECIST version 1.1;

• American Society of Anesthesiologists (ASA): I-II Class I-II, age ≥18 years, body mass index (BMI): 18.5-28 kg/m;

• Normal function of blood and vital organs such as heart, lungs and liver;

• Eligible to receive platinum-containing two-drug chemotherapy;

• Sign the informed consent form

Exclusion Criteria

• Prior treatment of any kind for current lung cancer, including chemotherapy or radiation therapy;

• Preoperative opioid analgesia;

• Locally advanced unresectable disease and metastatic disease;

• Any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to randomization;

• Active autoimmune disease or autoimmune disease that is likely to recur;

• History of interstitial lung disease, non-infectious pneumonia or poorly controlled disease (including pulmonary fibrosis, acute lung disease, etc.);

• Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection;

• History of antipsychotic medication in the last 6 months;

• Preoperative Mini-mental state examination (MMSE) score <23