Trial will test whether sugammadex protects older lung surgery patients from breathing problems better than neostigmine
A 530-patient randomized trial protocol will compare sugammadex and neostigmine for preventing breathing complications in older adults after lung resection.
Riepilogo
Older adults having lung cancer surgery face high risk of breathing problems afterward, partly because muscle-relaxant drugs given during surgery may not fully wear off. This paper is a protocol, not a results report, for a double-blinded randomized trial of 530 patients aged 65 and older undergoing thoracoscopic lung surgery with one-lung ventilation. Patients will receive either sugammadex or neostigmine to reverse neuromuscular blockade. The primary outcome is a composite of adverse respiratory events in the recovery room. Secondary outcomes include time to extubation, pulmonary and non-pulmonary complications, unplanned ICU admission, hospital stay, and 30-day mortality. No efficacy data exist yet, so the trial's findings could later inform reversal-drug choice in this vulnerable group.
Riepilogo Dettagliato
Why this matters: As populations age, more older adults are diagnosed with lung cancer and undergo surgical resection. Thoracoscopic (VATS) lung surgery requires one-lung ventilation, which strains gas exchange through ventilation-perfusion mismatch and alveolar injury. Older patients often have reduced physiological reserve, baseline lung dysfunction and frailty, so they are especially prone to adverse respiratory events (AREs) such as sustained hypoxemia, airway obstruction, aspiration, and unplanned non-invasive ventilation or re-intubation. Residual neuromuscular blockade (train-of-four ratio below 0.9) is a major modifiable risk factor. Reported incidence ranges from 26% to 88% depending on monitoring method and population, and even mild residual blockade can impair breathing, swallowing and airway patency.
What will be studied: Neostigmine has long been the standard reversal agent, but it depends on some spontaneous recovery already having occurred. It can be unreliable after deep blockade and carries dose-dependent side effects such as bradycardia, hypersalivation and postoperative nausea and vomiting. Sugammadex instead encapsulates aminosteroid blockers such as rocuronium and vecuronium, allowing rapid and complete reversal. Prior work has mostly examined surrogate endpoints such as recovery time or residual blockade, or has produced conflicting results on postoperative pulmonary complications. Older thoracic surgery patients have been underrepresented. This trial targets that gap with a clinically meaningful endpoint.
Design: This is a prospective, double-blinded, randomized controlled trial of 530 patients aged 65 or older scheduled for VATS lung surgery with one-lung ventilation. Participants are randomized 1:1 to sugammadex or neostigmine. The primary outcome is a composite of AREs occurring in the post-anaesthesia care unit (PACU). Secondary outcomes are time from neuromuscular blockade to extubation, a composite of AREs and rescue measures, PACU length of stay, postoperative pulmonary and extra-pulmonary complications, unplanned ICU admission, chest drainage tube duration, hospital length of stay, and mortality. Follow-up runs to 30 days after surgery, and the primary analysis uses a modified intention-to-treat approach. The trial is registered with the Chinese Clinical Trial Registry (ChiCTR2400094005) and funded by Shanghai public and institutional grants.
Implications: There are no results yet. If sugammadex reduces early respiratory events in this group, it could support its preferential use in older thoracic surgery patients. A null result would also help clarify whether its pharmacological advantages translate into better clinical outcomes.
Caveats: The text supplied was truncated after the introduction. Details such as dosing, monitoring procedures, sample-size assumptions, exact ARE definitions and the statistical plan could not be reviewed. This is a single-region, protocol-only publication, so no conclusions about efficacy or safety can be drawn.
Risultati Principali
- This is a protocol paper; no efficacy or safety results are reported yet.
- The trial will randomize 530 patients aged 65 or older 1:1 to sugammadex or neostigmine.
- The primary outcome is a composite of adverse respiratory events in the post-anaesthesia care unit.
- Secondary outcomes cover extubation time, pulmonary and extra-pulmonary complications, unplanned ICU admission, hospital stay and 30-day mortality.
- Residual neuromuscular blockade is reported in 26%–88% of patients, depending on monitoring method and population.
Metodologia
Prospective, double-blinded, 1:1 randomized controlled trial of 530 patients aged 65 or older undergoing VATS lung surgery with one-lung ventilation. The primary analysis is modified intention-to-treat, with the primary outcome a composite of PACU adverse respiratory events and follow-up to 30 days. It is registered as ChiCTR2400094005.
Limitazioni dello Studio
This is a protocol only, with no outcome data, and the provided text was truncated after the introduction, so sample-size justification, dosing, outcome definitions and statistical details could not be assessed. The trial's single-region setting may limit generalizability, and a modified intention-to-treat analysis can introduce some bias.
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