Clinical trial NCT05273827: Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunotherapy
Analgesia
NSCLC
Delirium
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University General Hospital
name: Tianjin Chest Hospital
First posted: 2022-03-10
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with NSCLC receiving neo-adjuvant chemotherapy or chemotherapy combined with immunotherapy followed by radical surgery will be screened and recruited in this study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: perioperative opioids consumption
timeFrame: from beginning of surgery to day 3 after surgery
Secondary outcomes:
measure: postoperative delirium
timeFrame: within 3 days after surgery
measure: score of Numerical Rating Scale
timeFrame: at the time of admission to the operating room, immediately after and at 24 hour, 48 hour, and 72h after entering the PICU
measure: analgesic pump press in PICU
timeFrame: day 1, 2 and 3 after surgery
measure: Percent of patients with moderate to severe pain within 72 hours
timeFrame: up to 72 hours after surgery
measure: intraoperative opioid consumption
timeFrame: from the beginning to the end of the surgery
measure: postoperative opioid consumption
timeFrame: up to 72 hours after surgery
Other outcomes:
measure: dosage of sedatives
timeFrame: intraoperative
measure: level of cytokines
timeFrame: before surgery and up to 24 hour after surgery
measure: Pathologic complete response (pCR) rate
timeFrame: up to 30 days after surgery
measure: ration of R0 resection
timeFrame: up to 30 days after surgery
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Chest Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Kaiyuan Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: