Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function
Recruiting now · Not applicable
Conditions studied: Residual Neuromuscular Block
In brief
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.
Key facts
- Study ID
- NCT07309393
- Run by
- Shanghai Pulmonary Hospital, Shanghai, China
- People needed
- 240
- Starts
- 2025-12-30
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2026-06-22
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (enrolling)
- Shanghai East Hospital,Affiliated to Tongji University — Shanghai, Shanghai Municipality, China (enrolling)
- Fudan university Shanghai cancer center — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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