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NCT07309393
Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function
Conditions: Residual Neuromuscular Block
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 240
Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Location: Shanghai Pulmonary Hospital Shanghai Shanghai Municipality
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 (\
Source: ClinicalTrials.gov (NCT07309393). StuddyBuddy aggregates publicly available trial information.