Clinical trial · Observational
Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium
Clinical Observation of the Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium in Patients With Non-small Cell Lung Cancer
NCT05273827CI-TRIAL-00072746completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Analgesia | — | UNRESOLVED | — |
| Delirium | — | UNRESOLVED | — |
| Immunotherapy | — | UNRESOLVED | — |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant chemotherapy | Drug | — | UNRESOLVED |
| neoadjuvant immunotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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
- interventionNames
- Drug: neoadjuvant immunotherapy
- label
- control group
- description
- platinum-containing dual-agent chemotherapy(cis-platinum and paclitaxel/pemetrexed)
- interventionNames
- Drug: Neoadjuvant chemotherapy
Primary outcomes (1)
- measure
- perioperative opioids consumption
- timeFrame
- from beginning of surgery to day 3 after surgery
- description
- the amount of sufentanil, remifentanil and morphine application.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWang K, Er J, Zhang Y, Song C, Yu Y, Gao R, Xu H, Dong X, Yuan L, Liu Q, Han J, Yu Y, Yin Y. Increased opioid consumption in neoadjuvant immunotherapy plus chemotherapy for patients with non-small-cell lung cancer: A multicenter, prospective cohort study. CNS Neurosci Ther. 2024 Aug;30(8):e14893. doi: 10.1111/cns.14893. PMID 39097916