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Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function

RecruitingNAAges 18 Years - 80 YearsAllShanghai Pulmonary Hospital, Shanghai, China
NCT07309393 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 ฮณ-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 (โ‰ค 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 (FEVโ‚) at 1 hour post-extubation compared to preoperative baseline; a โ‰ฅ 5% improve

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๐Ÿ“‹ Eligibility rules (as published)
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 refuse to participate. * Other situations deemed inappropriate by the investigators shall be accompanied by a statement of the reasons.
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What it tests

  • Sugammadex
  • Neostigmine
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Where

3 sites
Shanghai Pulmonary Hospital
Shanghai, China
Shanghai East Hospital,Affiliated to Tongji University
Shanghai, China
Fudan university Shanghai cancer center
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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