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

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05273827
• Other study ID #: bc2021131
• Status: Completed
• Start date: March 22, 2022
• Est. completion date: January 2, 2024

Study information

• Verified date: November 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 2, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Delirium
• Emergence Delirium
• Immunotherapy
• NSCLC

Intervention

Drug:
• neoadjuvant immunotherapy
Anti-PD-1 antibody was added to the conventional neoadjuvant chemotherapy.
• Neoadjuvant chemotherapy
Cis-platinum combined with paclitaxel or pemetrexed

Locations

Country	Name	City	State
China	Tianjin Chest Hospital	Tianjin
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin

Sponsors (3)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	Tianjin Chest Hospital, Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	dosage of sedatives	usage of propofol	intraoperative
Other	level of cytokines	IL-6, IL-10, TNF-a, sPD-L1	before surgery and up to 24 hour after surgery
Other	Pathologic complete response (pCR) rate	0% viable tumor in resected esophagus and lymph nodes	up to 30 days after surgery
Other	ration of R0 resection	surgical margin is microscopically-negative for residual tumor	up to 30 days after surgery
Primary	perioperative opioids consumption	the amount of sufentanil, remifentanil and morphine application.	from beginning of surgery to day 3 after surgery
Secondary	postoperative delirium	record the occurrence of postoperative delirium after surgery using the 3D-CAM test. Patient with postoperative delirium means worse outcome.	within 3 days after surgery
Secondary	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.	at the time of admission to the operating room, immediately after and at 24 hour, 48 hour, and 72h after entering the PICU
Secondary	analgesic pump press in PICU	the time of first analgesic pump press and no. of total press in PICU	day 1, 2 and 3 after surgery
Secondary	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.	up to 72 hours after surgery
Secondary	intraoperative opioid consumption	the amount of sufentanil and remifentanil	from the beginning to the end of the surgery
Secondary	postoperative opioid consumption	opioid usage in PCIA and supplemental analgesics within 72 h	up to 72 hours after surgery