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| Name | Class |
|---|---|
| Tianjin Medical University General Hospital | OTHER |
| Tianjin Chest Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neoadjuvant immunotherapy group | Anti-PD-1 monoclonal antibody (Nivolumab,Pembrolizumab, Sintilimab, or Sugemalimab) 200 mg intravenously in combination with cis-platinum and paclitaxel/pemetrexed |
| |
| control group | platinum-containing dual-agent chemotherapy(cis-platinum and paclitaxel/pemetrexed) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neoadjuvant immunotherapy | Drug | Anti-PD-1 antibody was added to the conventional neoadjuvant chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| perioperative opioids consumption | the amount of sufentanil, remifentanil and morphine application. | from beginning of surgery to day 3 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative delirium | record the occurrence of postoperative delirium after surgery using the 3D-CAM test. Patient with postoperative delirium means worse outcome. | within 3 days after surgery |
| score of Numerical Rating Scale |
| Measure | Description | Time Frame |
|---|---|---|
| dosage of sedatives | usage of propofol | intraoperative |
| level of cytokines | IL-6, IL-10, TNF-α, sPD-L1 | before surgery and up to 24 hour after surgery |
Inclusion Criteria:
Exclusion Criteria
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Patients with NSCLC receiving neo-adjuvant chemotherapy or chemotherapy combined with immunotherapy followed by radical surgery will be screened and recruited in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Kaiyuan Wang, MD | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | 300060 | China | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39097916 | Derived | Wang 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. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D017239 | Paclitaxel |
| D000068437 | Pemetrexed |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
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Blood samples will be obtained perioperatively. The serum will be further separated and frozen at -80 degrees.
| Neoadjuvant chemotherapy | Drug | Cis-platinum combined with paclitaxel or pemetrexed |
|
|
Record the patient's resting and motor Numerical Rating Scale (NRS) scores, range from 0 to 10, and higher score means more pain.
| at the time of admission to the operating room, immediately after and at 24 hour, 48 hour, and 72h after entering the PICU |
| analgesic pump press in PICU | the time of first analgesic pump press and no. of total press in PICU | day 1, 2 and 3 after surgery |
| Percent of patients with moderate to severe pain within 72 hours | Moderate to severe pain is defined as any NRS pain score of 4 or higher. | up to 72 hours after surgery |
| intraoperative opioid consumption | the amount of sufentanil and remifentanil | from the beginning to the end of the surgery |
| postoperative opioid consumption | opioid usage in PCIA and supplemental analgesics within 72 h | up to 72 hours after surgery |
| Pathologic complete response (pCR) rate | 0% viable tumor in resected esophagus and lymph nodes | up to 30 days after surgery |
| ration of R0 resection | surgical margin is microscopically-negative for residual tumor | up to 30 days after surgery |
| Tianjin Chest Hospital |
| Tianjin |
| China |
| Tianjin Medical University General Hospital | Tianjin | China |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003221 | Confusion |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003516 |
| Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |