Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function

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

Study Overview

• Status: Recruiting
• Conditions: Residual Neuromuscular Block
• Intervention / Treatment: Drug: Sugammadex; Drug: Neostigmine

Detailed Description

Detailed Description:

Background: Thoracoscopic lung surgery requires general anesthesia with double-lumen endotracheal intubation and muscle relaxants to facilitate lung isolation and surgical exposure. Residual neuromuscular blockade after surgery can cause complications such as airway obstruction, atelectasis, pneumonia, prolonged PACU stay, and reduced patient satisfaction. Neostigmine, a commonly used acetylcholinesterase inhibitor, reverses neuromuscular blockade by increasing acetylcholine but may cause cholinergic side effects, requiring atropine co-administration. Sugammadex, a γ-cyclodextrin compound, encapsulates and inactivates rocuronium directly, reversing blockade without affecting cholinergic receptors and avoiding related adverse events. Sugammadex can also shorten operation time and improve turnover efficiency in thoracoscopic surgery.

Purpose: This study aims to compare the effects of sugammadex and neostigmine on early postoperative pulmonary function recovery in patients undergoing thoracoscopic lung resection, providing reliable clinical data to improve surgical management and enhance recovery.

Design: Patients planned for unilateral thoracoscopic lung segmentectomy will be randomized 1:1 to receive either sugammadex or neostigmine plus atropine for reversal of rocuronium-induced neuromuscular blockade at the end of surgery. Pulmonary function will be assessed using a portable spirometer before surgery and at postoperative 1 hour, 1 to 3 days, or before discharge. Other outcomes including postoperative pain, opioid consumption, gastrointestinal recovery, incidence of nausea/vomiting, quality of recovery (QoR-15 scale) will be evaluated.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shiyou Wei, PhD; Phone Number: 8615601680288; Email: lovewishyou@163.com
• Study Contact Backup: Name: Xin Lv, PhD; Phone Number: 8618852869700; Email: xinlvg@126.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Dandan Ling; Phone Number: 0216417559001; Email: lddyue@163.com
      • Contact: Jun Zhang; Phone Number: 0216417559001-1066
    • Shanghai, Shanghai Municipality, China, 200082
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Shiyou Wei, MD; Phone Number: 2260 86-021-65115006; Email: lovewishyou@163.com
      • Contact: Jiong Song, MD; Phone Number: 86-15601680288; Email: sw480@126.com
    • Shanghai, Shanghai Municipality, China, 200120
      • Recruiting
      • Shanghai East Hospital,Affiliated to Tongji University
      • Contact: Jie Wu, MD.; Phone Number: 8613262702619; Email: wujie20156@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Sugammadex; Sugammadex is administered intravenously at a dose of 2 mg/kg 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 a total volume of 10 mL in an identical syringe to maintain blinding. Administration occurs when the patient shows signs of awakening (e.g., TOF ratio 0.4-0.9 or full awakening). This is a single-dose intervention given once at the conclusion of surgery. Associated with the Sugammadex Group (experimental arm).; Other Names: HengShu, Sugammadex sodium
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.	Drug: Neostigmine; Neostigmine (0.03 mg/kg) combined with atropine (0.015 mg/kg) is administered intravenously 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 a total volume of 10 mL in an identical syringe to maintain blinding. Administration occurs when the patient shows signs of awakening (e.g., TOF ratio 0.4-0.9 or full awakening). This is a single-dose intervention given once at the conclusion of surgery. Associated with the Neostigmine Group (active comparator arm).; Other Names: Neostigmine methylsulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Forced Expiratory Volume in 1 Second (FEV1) from Baseline to 1 Hour Postoperatively	The percentage decline in FEV1 (measured using a portable spirometer) at 1 hour after unilateral thoracoscopic lung segmentectomy surgery, compared to the preoperative baseline value. FEV1 represents the volume of air exhaled in the first second of a forced expiratory maneuver. The decline is calculated as [(preoperative FEV1 - postoperative FEV1) / preoperative FEV1] × 100%. A smaller decline indicates better early postoperative pulmonary function recovery.	Preoperative (baseline, within 7 days before surgery) and 1 hour postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Forced Expiratory Volume in 1 Second (FEV1) from Baseline to Later Postoperative Time Points	The percentage decline in FEV1 (measured using a portable spirometer) at postoperative day 1-3 or before discharge, compared to the preoperative baseline value. FEV1 represents the volume of air exhaled in the first second of a forced expiratory maneuver. The decline is calculated as [(preoperative FEV1 - postoperative FEV1) / preoperative FEV1] × 100%. A smaller decline indicates better postoperative pulmonary function recovery.	Preoperative (baseline, within 7 days before surgery) and postoperative day 1-3 or before discharge.
Postoperative Pain Score	Postoperative pain intensity assessed using the Verbal Response Scale (VRS), the score ranges from 0 to 10, with a total of 11 numbers corresponding to different pain levels: 0 indicates no pain; 1-3 indicates mild pain (tolerable and does not affect sleep); 4-6 indicates moderate pain (significant, affects sleep, and requires medication for relief); and 7-10 indicates severe pain (intense, intolerable, and severely affects life).	Postoperative 1 hour and postoperative day 1-3.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Opioid Consumption	Total cumulative opioid dosage (in morphine equivalents) administered postoperatively, including patient-controlled analgesia and rescue doses .	Postoperative day 1-2 (up to 48 hours after surgery).
Neuromuscular Recovery (TOF Ratio)	Train-of-Four (TOF) ratio measured using a neuromuscular monitor on the ulnar nerve at the end of surgery. The TOF ratio is recorded as T4/T1, with a ratio ≥0.9 indicating complete neuromuscular recovery from rocuronium-induced blockade.	At the end of surgery and 1 hour postoperative.
Gastrointestinal Function Recovery	The time to first postoperative gastrointestinal flatus	Postoperative day 1-3.
Quality of Recovery (QoR-15 Score)	Postoperative recovery quality assessed using the Quality of Recovery-15 (QoR-15) questionnaire, a patient-reported scale covering emotional state, physical comfort, psychological support, physical independence, and pain. Scores range from 0 to 150, with higher scores indicating better recovery quality.	Postoperative day 1-3
Postoperative nausea and vomiting	Record the number of patients who experienced postoperative nausea and vomiting (PONV).	Postoperative 6, 24, 48, and 72 hours.
Number of Participants With Postoperative Pulmonary Complications (PPCs)	Postoperative pulmonary complications (PPCs) mainly include pulmonary infection, atelectasis, acute respiratory distress syndrome (ARDS) and aspiration. Pneumonia: Defined in accordance with the criteria of the U.S. Centers for Disease Control and Prevention (CDC). Two or more consecutive chest radiographs showing at least one of the following manifestations (only one chest radiograph is required for patients without underlying pulmonary or cardiac diseases): (i) new, progressive and persistent infiltration; (ii) consolidation; (iii) cavitation. Atelectasis: Confirmed by chest X-ray and computed tomography (CT). ARDS: Defined per the 2012 Berlin Consensus. Onset within 1 week of a known clinical cause, or new onset or exacerbation of existing respiratory symptoms; presence of bilateral opacities on chest X-ray or CT scan, combined with corresponding hypoxemia. Aspiration: Confirmed by a clear clinical history plus imaging evidence.	Within 72 hours postoperatively
Length of Postoperative Hospital Stay	Time from the end of surgery to hospital discharge	From the end of surgery until the date of hospital discharge, assessed up to 30 days postoperatively
Train-of-Four Stimulation	Train-of-four stimulation for neuromuscular function monitoring is a classic electrophysiological test method used in anesthesiology to assess the function of the neuromuscular junction. This test involves delivering four consecutive electrical stimuli to the ulnar nerve (the most commonly used nerve), then observing the contractile response of the adductor pollicis muscle. The degree of neuromuscular block is quantified by the train-of-four (TOF) ratio, which is also used to determine the residual effect of muscle relaxants and the recovery status of neuromuscular function. A TOF ratio of ≥0.9 is universally recognized in clinical practice as the criterion for the complete recovery of neuromuscular function.	At the end of surgery, 1 hour after the end of surgery.

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Study Director: Xin Lv, PhD, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 3, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Lung Resection; Quality of Recovery; Sugammadex; Neostigmine; Forced Expiratory Volume (FEV1)
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Delayed Emergence from Anesthesia; Organic Chemicals; Carbohydrates; Polycyclic Compounds; Amines; Polysaccharides; Macrocyclic Compounds; Phenylammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds; gamma-Cyclodextrins; Cyclodextrins; Dextrins; Starch; Glucans; Neostigmine; Sugammadex
• Other Study ID Numbers: 2025LY0107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No