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Esophageal Neoplasms / Esophageal Cancer / Neoadjuvant Immunochemotherapy · Journal article
Annals of Medicine · July 29, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a protocol for a prospective observational cohort study designed to evaluate whether neoadjuvant immunochemotherapy affects intraoperative remifentanil requirements during esophagectomy in elderly patients, monitored using IoC2 depth-of-anesthesia technology. No results are reported; the study has not yet been conducted and represents a planned investigation.
Prospective observational cohort study. Elderly patients with esophageal cancer scheduled for esophagectomy; stratified by neoadjuvant immunochemotherapy status (prior treatment vs. treatment-naive).. Intervention: Neoadjuvant immunochemotherapy (nICT) prior to esophagectomy with IoC2-guided anesthesia.. Compared with: Treatment-naive group receiving esophagectomy with IoC2-guided anesthesia.. n = 60. Jiangsu Cancer Hospital, China..
Primary outcome: mean intraoperative remifentanil infusion rate (μg/kg/min) will be compared between nICT (n=30) and treatment-naive (n=30) groups Secondary outcomes include total intraoperative sufentanil dose, postoperative opioid consumption at multiple time points (PACU, 12, 24, 48, 72 h), pain scores, PCIA attempts, rescue analgesia use, incidence of moderate-to-severe pain (NRS ≥ 4), delirium, postoperative complications, chest tube removal time, and hospital length of stay
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
If completed as designed, this study will provide preliminary evidence on whether neoadjuvant immunochemotherapy alters opioid requirements during esophageal cancer surgery, potentially informing individualized anesthetic-analgesic planning. Results remain pending and cannot guide current practice.
This is a protocol for a prospective observational cohort study not yet conducted; it describes planned methods and outcomes without results, establishing hypothesis-generating potential but lacking empirical evidence.
As stated by the source record.
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If completed as designed, this study will provide preliminary evidence on whether neoadjuvant immunochemotherapy alters opioid requirements during esophageal cancer surgery, potentially informing individualized anesthetic-analgesic planning. Results remain pending and cannot guide current practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Background. 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.Methods. 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.Discussion. 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.Trial registration. The study protocol is registered with the Chinese Clinical Trial Registry under registration number ChiCTR2500105958, dated July 15, 2025.
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