Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: neoadjuvant immunotherapy group Anti-PD-1 monoclonal antibody (Nivolumab,Pembrolizumab, Sintilimab, or Sugemalimab) 200 mg intravenously in combination with cis-platinum and paclitaxel/pemetrexed |
Drug: neoadjuvant immunotherapy
Anti-PD-1 antibody was added to the conventional neoadjuvant chemotherapy.
Other Names:
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Placebo Comparator: control group platinum-containing dual-agent chemotherapy(cis-platinum and paclitaxel/pemetrexed) |
Drug: Neoadjuvant chemotherapy
Cis-platinum combined with paclitaxel or pemetrexed
Other Names:
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Outcome Measures
Primary Outcome Measures
- perioperative opioids usage [from beginning of surgery to day 3 after surgery]
the amount of sufentanil, remifentanil and morphine application.
- postoperative delirium [within 3 days after surgery]
record the occurrence of postoperative delirium after surgery using the 3D-CAM test. Patient with postoperative delirium means worse outcome.
- analgesic pump press in PICU [day 1 after surgery]
the time of first analgesic pump press in PICU
Secondary Outcome Measures
- score of visual analog scale [at the time of admission to the operating room, immediately after and at 24 hour, 48 hour after entering the PICU]
Record the patient's resting and motor visual analog scale (VAS) scores, range from 0 to 10, and higher score means more pain.
- dosage of sedatives [intraoperative]
usage of propofol
- level of cytokines [up to 24 hour after surgery]
IL-6, IL-10, TNF-α
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed stage II or stage IIIA non-small cell lung cancer and meet the requirements for R0 resection;
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Has measurable disease assessed according to RECIST version 1.1;
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American Society of Anesthesiologists (ASA): I-II Class I-II, age ≥18 years, body mass index (BMI): 18.5-28 kg/m;
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Normal function of blood and vital organs such as heart, lungs and liver;
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Eligible to receive platinum-containing two-drug chemotherapy;
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Sign the informed consent form
Exclusion Criteria
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Prior treatment of any kind for current lung cancer, including chemotherapy or radiation therapy;
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Preoperative opioid analgesia;
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Locally advanced unresectable disease and metastatic disease;
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Any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to randomization;
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Active autoimmune disease or autoimmune disease that is likely to recur;
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History of interstitial lung disease, non-infectious pneumonia or poorly controlled disease (including pulmonary fibrosis, acute lung disease, etc.);
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Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection;
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History of antipsychotic medication in the last 6 months;
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Preoperative Mini-mental state examination (MMSE) score <23
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin | China | 300060 |
2 | Tianjin Chest Hospital | Tianjin | China | ||
3 | Tianjin Medical University General Hospital | Tianjin | China |
Sponsors and Collaborators
- Tianjin Medical University Cancer Institute and Hospital
- Tianjin Medical University General Hospital
- Tianjin Chest Hospital
Investigators
- Principal Investigator: Kaiyuan Wang, MD, Tianjin Medical University Cancer Institute and Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- bc2021131