Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium

Tianjin Medical University Cancer Institute and Hospital81 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Immunotherapy Analgesia NSCLC Delirium

Interventions

neoadjuvant immunotherapyDRUG

Anti-PD-1 antibody was added to the conventional neoadjuvant chemotherapy.

Neoadjuvant chemotherapyDRUG

Cis-platinum combined with paclitaxel or pemetrexed

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Tianjin Chest Hospital

Tianjin, China

Tianjin Medical University General Hospital

Tianjin, China

Outcomes

Primary Outcomes

perioperative opioids consumption

the amount of sufentanil, remifentanil and morphine application.

Time frame: from beginning of surgery to day 3 after surgery

Secondary Outcomes

postoperative delirium

record the occurrence of postoperative delirium after surgery using the 3D-CAM test. Patient with postoperative delirium means worse outcome.

Time frame: within 3 days after surgery

score of Numerical Rating Scale

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: 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

Time frame: 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.

Time frame: up to 72 hours after surgery

intraoperative opioid consumption

the amount of sufentanil and remifentanil

Time frame: from the beginning to the end of the surgery

postoperative opioid consumption

opioid usage in PCIA and supplemental analgesics within 72 h

Time frame: up to 72 hours after surgery

Data from ClinicalTrials.gov

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