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Recruiting NCT07309393

Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function

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Trial Parameters

Condition Residual Neuromuscular Block
Sponsor Shanghai Pulmonary Hospital, Shanghai, China
Study Type INTERVENTIONAL
Phase N/A
Enrollment 240
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2025-12-31
Completion 2026-06-25
Interventions
SugammadexNeostigmine

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Brief 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.

Eligibility Criteria

Inclusion Criteria: * Scheduled for elective unilateral thoracoscopic partial lung resection, with expected resection not exceeding one lung segment. * Age between 18 and 80 years. * American Society of Anesthesiologists (ASA) Physical Status classification I-III. Exclusion Criteria: * Contraindications to drug use, such as history of allergy, epilepsy, angina, ventricular tachycardia; contraindicated in patients with mechanical intestinal obstruction or urinary tract obstruction; contraindicated in cases of arrhythmia, bradycardia (\<50 beats per minute), hypotension, or increased vagal tone; contraindicated in patients currently using depolarizing muscle relaxants (e.g., succinylcholine). * Inability to correctly cooperate with portable lung function testing. * Hepatic or renal insufficiency. * Pregnancy, lactation, potential for pregnancy, or planning pregnancy. * Preoperative history of drug abuse or addiction. * Second surgery during postoperative hospitalization. * Patients who r

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