Protocol for a cohort study: evaluating the effect of neoadjuvant immunochemotherapy on intraoperative remifentanil consumption during IoC2-guided anesthesia in elderly patients with esophageal cancer.
The influence of neoadjuvant immunochemotherapy (nICT) on intraoperative opioid consumption during esophagectomy for cancer is not well understood. IoC2 enables real-time antinociceptive depth monitoring. This study assesses nICT's effect on remifentanil requirements in elderly patients using IoC2.
This prospective observational cohort study will be conducted at Jiangsu Cancer Hospital. Sixty patients scheduled for esophagectomy will be enrolled. Patients will be divided into the nICT group (n = 30) or the treatment-naive group (n = 30). All patients will receive a standardized anesthetic protocol. The primary outcome is the mean intraoperative remifentanil infusion rate (μg/kg/min). Secondary outcomes include: total intraoperative dose of sufentanil; postoperative cumulative opioid consumption at PACU, 12, 24, 48, and 72 h; pain scores, PCIA attempts, and rescue analgesia use at PACU, 12, 24, 48, and 72 h post-surgery, and the incidence of moderate-to-severe pain (NRS ≥ 4) at these time points; as well as delirium, postoperative complications, chest tube removal time, and hospital length of stay.
This study aims to clarify the effect of neoadjuvant therapy on opioid requirements during esophageal cancer surgery. By employing precise IoC2 monitoring, we aim to establish a methodological basis for developing individualized, precise anesthesia-analgesia strategies and to provide prospective evidence for their clinical application.
The study protocol is registered with the Chinese Clinical Trial Registry under registration number ChiCTR2500105958, dated July 15, 2025.
This prospective observational cohort study will be conducted at Jiangsu Cancer Hospital. Sixty patients scheduled for esophagectomy will be enrolled. Patients will be divided into the nICT group (n = 30) or the treatment-naive group (n = 30). All patients will receive a standardized anesthetic protocol. The primary outcome is the mean intraoperative remifentanil infusion rate (μg/kg/min). Secondary outcomes include: total intraoperative dose of sufentanil; postoperative cumulative opioid consumption at PACU, 12, 24, 48, and 72 h; pain scores, PCIA attempts, and rescue analgesia use at PACU, 12, 24, 48, and 72 h post-surgery, and the incidence of moderate-to-severe pain (NRS ≥ 4) at these time points; as well as delirium, postoperative complications, chest tube removal time, and hospital length of stay.
This study aims to clarify the effect of neoadjuvant therapy on opioid requirements during esophageal cancer surgery. By employing precise IoC2 monitoring, we aim to establish a methodological basis for developing individualized, precise anesthesia-analgesia strategies and to provide prospective evidence for their clinical application.
The study protocol is registered with the Chinese Clinical Trial Registry under registration number ChiCTR2500105958, dated July 15, 2025.