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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-22

Study Completion Date

2024-01-02

Brief Summary

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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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Detailed Description

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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.

Conditions

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Immunotherapy Analgesia NSCLC Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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neoadjuvant immunotherapy group

Anti-PD-1 monoclonal antibody (Nivolumab，Pembrolizumab, Sintilimab, or Sugemalimab) 200 mg intravenously in combination with cis-platinum and paclitaxel/pemetrexed

neoadjuvant immunotherapy

Intervention Type DRUG

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

control group

platinum-containing dual-agent chemotherapy(cis-platinum and paclitaxel/pemetrexed)

Neoadjuvant chemotherapy

Intervention Type DRUG

Cis-platinum combined with paclitaxel or pemetrexed

Interventions

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neoadjuvant immunotherapy

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

Intervention Type DRUG

Neoadjuvant chemotherapy

Cis-platinum combined with paclitaxel or pemetrexed

Intervention Type DRUG

Other Intervention Names

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anti-PD-1 therapy Cis-platinum combined with paclitaxel or pemetrexed

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No