NCT07309393 Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function
| NCT ID | NCT07309393 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China |
| Condition | Residual Neuromuscular Block |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-12-30 |
| Primary Completion | 2026-09-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2025-12-30 with a primary completion date of 2026-09-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 refuse to participate. * Other situations deemed inappropriate by the investigators shall be accompanied by a statement of the reasons.
Contact & Investigator
Xin Lv, PhD
STUDY DIRECTOR
Shanghai Pulmonary Hospital, Tongji University, Shanghai, China
Frequently Asked Questions
Who can join the NCT07309393 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Residual Neuromuscular Block. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07309393 currently recruiting?
Yes, NCT07309393 is actively recruiting participants. Contact the research team at lovewishyou@163.com for enrollment information.
Where is the NCT07309393 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China, Shanghai, China.
Who is sponsoring the NCT07309393 clinical trial?
NCT07309393 is sponsored by Shanghai Pulmonary Hospital, Shanghai, China. The principal investigator is Xin Lv, PhD at Shanghai Pulmonary Hospital, Tongji University, Shanghai, China. The trial plans to enroll 240 participants.