Clinical Trial

Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function

Recruiting
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Summary
Residual neuromuscular blockade (NMB) after general anesthesia increases the risk of postoperative respiratory complications (atelectasis, pneumonia, re-intubation) and delays pulmonary function recovery. Sugammadex, a γ-cyclodextrin that directly encapsulates rocuronium, reverses NMB rapidly and completely without cholinergic side effects, whereas neostigmine requires co-administration of an antimuscarinic and may leave residual blockade. In this multicenter, randomized, double-blind, controlled trial, 240 adult patients (ASA I-III) undergoing elective thoracoscopic lung resection (≤ 1 segment) will be randomized 1:1 to receive sugammadex (2 mg/kg) or neostigmine (0.03 mg/kg) + atropine (0.015 mg/kg) at the end of surgery. The primary endpoint is the percent decline in forced expiratory volume in 1 second (FEV₁) at 1 hour post-extubation compared to preoperative baseline; a ≥ 5% improvement with sugammadex is hypothesized. Secondary endpoints include FEV₁ at days 1-3, pain scores, opioid consumption, gastrointestinal recovery, quality of recovery (QoR-15), neuromuscular monitoring (TOF ratio), and incidence of postoperative pulmonary and surgical complications.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-06-25 -> 2026-09-25 2026-06-23
minor Completion pushed: 2026-06-30 -> 2026-09-30 2026-06-23
Trial Details
NCT Number NCT07309393
Lead Sponsor Shanghai Pulmonary Hospital, Shanghai, China
Conditions Residual Neuromuscular Block
Enrollment 240 participants
Start Date 2025-12-30
Primary Completion 2026-09-25 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-22