Effect of Neoadjuvant Anti-PD-1 Immunotherapy on Perioperative Analgesia and Postoperative Delirium
- Conditions
- ImmunotherapyAnalgesiaDeliriumNSCLC
- Interventions
- Drug: neoadjuvant immunotherapyDrug: Neoadjuvant chemotherapy
- Registration Number
- NCT05273827
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description neoadjuvant immunotherapy group neoadjuvant immunotherapy Anti-PD-1 monoclonal antibody (Nivolumab，Pembrolizumab, Sintilimab, or Sugemalimab) 200 mg intravenously in combination with cis-platinum and paclitaxel/pemetrexed control group Neoadjuvant chemotherapy platinum-containing dual-agent chemotherapy(cis-platinum and paclitaxel/pemetrexed)
- Primary Outcome Measures
Name Time Method perioperative opioids consumption from beginning of surgery to day 3 after surgery the amount of sufentanil, remifentanil and morphine application.
- Secondary Outcome Measures
Name Time Method 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.
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.
intraoperative opioid consumption from the beginning to the end of the surgery the amount of sufentanil and remifentanil
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
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.
postoperative opioid consumption up to 72 hours after surgery opioid usage in PCIA and supplemental analgesics within 72 h
Trial Locations
- Locations (3)
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Chest Hospital
🇨🇳Tianjin, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China