Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Sugammadex
  • Neostigmine

Treatment groups

240 Participants
are divided into 2 treatment groups