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

Tianjin Medical University

Status: Completed

Conditions: Delirium; Immunotherapy; Analgesia; NSCLC

Treatments: Drug: Neoadjuvant chemotherapy; Drug: neoadjuvant immunotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT05273827

bc2021131

Details and patient eligibility

About

To observe the effect of preoperative anti-PD-1 monotherapy combined with chemotherapy on patients' perioperative pain and opioid analgesia, and evaluate its effect on the incidence and severity of patients' postoperative delirium.

Full description

In this study, the investigators intend to select patients with resectable NSCLC treated with immuno-neoadjuvant therapy in combination with chemotherapy, 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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Histologically confirmed stage II or stage IIIA non-small cell lung cancer (NSCLC) and meet the requirements for R0 resection;
• American Society of Anesthesiologists (ASA): I-III, age ≥18 years, body mass index (BMI): 18.5-30;
• Normal function of Coagulation and vital organs such as heart, lungs, kidney, 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, radiation or targeted therapy;
• Preoperative opioid analgesia;
• 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

Trial design

81 participants in 2 patient groups

neoadjuvant immunotherapy group

Description:

Anti-PD-1 monoclonal antibody (Nivolumab，Pembrolizumab, Sintilimab, or Sugemalimab) 200 mg intravenously in combination with cis-platinum and paclitaxel/pemetrexed

Treatment:

Drug: neoadjuvant immunotherapy

control group

Description:

platinum-containing dual-agent chemotherapy(cis-platinum and paclitaxel/pemetrexed)

Treatment:

Drug: Neoadjuvant chemotherapy