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NCT Number: NCT05273827

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neoadjuvant immunotherapy

Drug

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

Other names: anti-PD-1 therapy

Neoadjuvant chemotherapy

Drug

Cis-platinum combined with paclitaxel or pemetrexed

Other names: Cis-platinum combined with paclitaxel or pemetrexed

Primary outcomes

  1. perioperative opioids consumption

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

    the amount of sufentanil, remifentanil and morphine application.

Secondary outcomes

  1. postoperative delirium

    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.

  2. score of Numerical Rating Scale

    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.

  3. analgesic pump press in PICU

    Time frame: day 1, 2 and 3 after surgery

    the time of first analgesic pump press and no. of total press in PICU

  4. Percent of patients with moderate to severe pain within 72 hours

    Time frame: up to 72 hours after surgery

    Moderate to severe pain is defined as any NRS pain score of 4 or higher.

  5. intraoperative opioid consumption

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

    the amount of sufentanil and remifentanil

  6. postoperative opioid consumption

    Time frame: up to 72 hours after surgery

    opioid usage in PCIA and supplemental analgesics within 72 h

Other outcomes

  1. dosage of sedatives

    Time frame: intraoperative

    usage of propofol

  2. level of cytokines

    Time frame: before surgery and up to 24 hour after surgery

    IL-6, IL-10, TNF-α, sPD-L1

  3. Pathologic complete response (pCR) rate

    Time frame: up to 30 days after surgery

    0% viable tumor in resected esophagus and lymph nodes

  4. ration of R0 resection

    Time frame: up to 30 days after surgery

    surgical margin is microscopically-negative for residual tumor

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Collaborators

  • Tianjin Chest Hospital
  • Tianjin Medical University General Hospital

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 10, 2022
Registry last updated
Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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