Actively Recruiting
Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2026-03-27
240
Participants Needed
3
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for elective unilateral thoracoscopic partial lung resection, with expected removal not exceeding one lung segment
- Age between 18 and 80 years
- Classified as ASA Physical Status I-III
You will not qualify if you...
- History of allergy, epilepsy, angina, ventricular tachycardia, or contraindications to study drugs
- Mechanical intestinal or urinary tract obstruction
- Arrhythmia, bradycardia (below 50 beats per minute), hypotension, or increased vagal tone
- Current use of depolarizing muscle relaxants (e.g., succinylcholine)
- Unable to cooperate with lung function testing
- Liver or kidney insufficiency
- Pregnant, breastfeeding, potential for pregnancy, or planning pregnancy
- History of drug abuse or addiction
- Undergoing a second surgery during postoperative hospitalization
- Refusal to participate
- Other reasons deemed inappropriate by investigators with explanation
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200082
Actively Recruiting
2
Shanghai East Hospital,Affiliated to Tongji University
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
3
Fudan university Shanghai cancer center
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
S
Shiyou Wei, PhD
CONTACT
X
Xin Lv, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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