Sugammadex versus neostigmine on postoperative adverse respiratory events in elderly patients undergoing lung resection: study protocol for a randomized controlled trial

Abstract

Background: Elderly patients undergoing lung resection are particularly susceptible to postoperative adverse respiratory events (AREs), due to age-related physiological decline and a higher incidence of residual neuromuscular blockade (RNMB). Sugammadex is a selective relaxant binding agent that enables rapid and complete reversal of aminosteroid neuromuscular blocking agents such as rocuronium, offering potential advantages over traditional acetylcholinesterase inhibitors like neostigmine. However, evidence directly comparing the impact of sugammadex versus neostigmine on clinically relevant respiratory outcomes, particularly AREs in elderly patients undergoing lung resection remains limited.

Methods and analysis: This is a prospective, double-blinded, randomized controlled clinical trial involving 530 elderly patients (≥65 years old) scheduled for video-assisted thoracoscopic lung surgery requiring one-lung ventilation. Patients will be 1:1 randomized to receive sugammadex or neostigmine for neuromuscular blockade reversal. The primary outcome is a composite of AREs occurring in the post-anaesthesia care unit (PACU). Secondary outcomes include time from neuromuscular to extubation, the composite of ARE and rescue measures, PACU length of stay, postoperative pulmonary and extra-pulmonary complications, unplanned intensive care unit (ICU) admission, chest drainage tube duration, hospital length of stay, and mortality. All patients will be followed up until 30 days after surgery. The primary analysis will be conducted on a modified intention-to-treat basis.

Discussion: This trial is designed to address a critical gap in perioperative care for elderly patients undergoing lung resection by directly comparing sugammadex and neostigmine in terms of clinically meaningful respiratory outcomes. While previous studies have primarily focused on pharmacokinetic profiles or surrogate markers such as train-of-four recovery time, evidence regarding the impact of these agents on postoperative AREs remains limited. Given the growing elderly surgical population and the high incidence of RNMB and pulmonary complications in this group, the findings of this study will offer valuable insight into optimizing neuromuscular blockade reversal strategies.

Trial registration: This study is registered at Chinese clinical trial registry (ChiCTR2400094005).

Keywords: Adverse respiratory events; elderly; lung resection; neostigmine; sugammadex.

Figure 1.

Study flowchart. ASA: American Society of Anesthesiologists; VATS: video-assisted thoracic lung surgery.