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Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function After Thoracoscopic Lung Resection: A Multicenter, Randomized, Double-Blind, Controlled Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Fudan university Shanghai cancer center
RECRUITING
Shanghai
Shanghai East Hospital,Affiliated to Tongji University
RECRUITING
Shanghai
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Contact Information
Primary
Shiyou Wei, PhD
lovewishyou@163.com
8615601680288
Backup
Xin Lv, PhD
xinlvg@126.com
8618852869700
Time Frame
Start Date: 2025-12-31
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 240
Treatments
Experimental: Sugammadex Group
Participants in this experimental arm receive sugammadex (2 mg/kg IV) for reversal of rocuronium-induced neuromuscular blockade at the end of unilateral thoracoscopic lung segmentectomy surgery. The drug is prepared by an independent anesthesia nurse, diluted in normal saline to 10 mL, and administered when the patient shows signs of awakening (e.g., TOF ratio 0.4-0.9 or full awakening). This arm includes 120 participants randomized in a 1:1 ratio. Postoperative assessments focus on pulmonary function recovery, pain, and complications.
Active_comparator: Neostigmine Group
Participants in this active comparator arm receive neostigmine (0.03 mg/kg IV) plus atropine (0.015 mg/kg IV) for reversal of rocuronium-induced neuromuscular blockade at the end of unilateral thoracoscopic lung segmentectomy surgery. The drugs are prepared by an independent anesthesia nurse, diluted in normal saline to 10 mL, and administered when the patient shows signs of awakening (e.g., TOF ratio 0.4-0.9 or full awakening). This arm includes 120 participants randomized in a 1:1 ratio. Postoperative assessments focus on pulmonary function recovery, pain, and complications.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Pulmonary Hospital, Shanghai, China

This content was sourced from clinicaltrials.gov