Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT07309393

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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