neoadjuvant immunotherapy
DrugAnti-PD-1 antibody was added to the conventional neoadjuvant chemotherapy.
Other names: anti-PD-1 therapy
NCT Number: NCT05273827
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.
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All sexes
Observational
Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Anti-PD-1 antibody was added to the conventional neoadjuvant chemotherapy.
Other names: anti-PD-1 therapy
Cis-platinum combined with paclitaxel or pemetrexed
Other names: Cis-platinum combined with paclitaxel or pemetrexed
Time frame: from beginning of surgery to day 3 after surgery
the amount of sufentanil, remifentanil and morphine application.
Time frame: 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.
Time frame: 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.
Time frame: day 1, 2 and 3 after surgery
the time of first analgesic pump press and no. of total press in PICU
Time frame: up to 72 hours after surgery
Moderate to severe pain is defined as any NRS pain score of 4 or higher.
Time frame: from the beginning to the end of the surgery
the amount of sufentanil and remifentanil
Time frame: up to 72 hours after surgery
opioid usage in PCIA and supplemental analgesics within 72 h
Time frame: intraoperative
usage of propofol
Time frame: before surgery and up to 24 hour after surgery
IL-6, IL-10, TNF-α, sPD-L1
Time frame: up to 30 days after surgery
0% viable tumor in resected esophagus and lymph nodes
Time frame: up to 30 days after surgery
surgical margin is microscopically-negative for residual tumor
Tianjin Medical University Cancer Institute and Hospital
Other
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
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