Analgesia, Delirium, Immunotherapy, NSCLC
Conditions
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.
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.
Interventions
DRUGneoadjuvant immunotherapy
Anti-PD-1 antibody was added to the conventional neoadjuvant chemotherapy.
DRUGNeoadjuvant chemotherapy
Cis-platinum combined with paclitaxel or pemetrexed
Sponsors
Tianjin Medical University General Hospital
Tianjin Chest Hospital
Tianjin Medical University Cancer Institute and Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| perioperative opioids consumption | from beginning of surgery to day 3 after surgery | the amount of sufentanil, remifentanil and morphine application. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| score of Numerical Rating Scale | at the time of admission to the operating room, immediately after and at 24 hour, 48 hour, and 72h after entering the PICU | Record the patient's resting and motor Numerical Rating Scale (NRS) scores, range from 0 to 10, and higher score means more pain. |
| analgesic pump press in PICU | day 1, 2 and 3 after surgery | the time of first analgesic pump press and no. of total press in PICU |
| Percent of patients with moderate to severe pain within 72 hours | up to 72 hours after surgery | Moderate to severe pain is defined as any NRS pain score of 4 or higher. |
| intraoperative opioid consumption | from the beginning to the end of the surgery | the amount of sufentanil and remifentanil |
| postoperative opioid consumption | up to 72 hours after surgery | opioid usage in PCIA and supplemental analgesics within 72 h |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pathologic complete response (pCR) rate | up to 30 days after surgery | 0% viable tumor in resected esophagus and lymph nodes |
| ration of R0 resection | up to 30 days after surgery | surgical margin is microscopically-negative for residual tumor |
| level of cytokines | before surgery and up to 24 hour after surgery | IL-6, IL-10, TNF-α, sPD-L1 |
| dosage of sedatives | intraoperative | usage of propofol |
Countries
China
Outcome results
None listed