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NCT Number: NCT07309393

Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function

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.

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Key information

Conditions

Residual Neuromuscular Block Delayed Emergence from Anesthesia Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fudan university Shanghai cancer center, Shanghai, Shanghai Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sugammadex

Drug

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

Neostigmine

Drug

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

Primary outcomes

  1. Change in Forced Expiratory Volume in 1 Second (FEV1) from Baseline to 1 Hour Postoperatively

    Time frame: Preoperative (baseline, within 7 days before surgery) and 1 hour postoperative.

    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.

Secondary outcomes

  1. Change in Forced Expiratory Volume in 1 Second (FEV1) from Baseline to Later Postoperative Time Points

    Time frame: Preoperative (baseline, within 7 days before surgery) and postoperative day 1-3 or before discharge.

    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.

  2. Postoperative Pain Score

    Time frame: Postoperative 1 hour and postoperative day 1-3.

    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).

Other outcomes

  1. Cumulative Opioid Consumption

    Time frame: Postoperative day 1-2 (up to 48 hours after surgery).

    Total cumulative opioid dosage (in morphine equivalents) administered postoperatively, including patient-controlled analgesia and rescue doses .

  2. Neuromuscular Recovery (TOF Ratio)

    Time frame: At the end of surgery and 1 hour postoperative.

    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.

  3. Gastrointestinal Function Recovery

    Time frame: Postoperative day 1-3.

    The time to first postoperative gastrointestinal flatus

  4. Quality of Recovery (QoR-15 Score)

    Time frame: Postoperative day 1-3

    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.

  5. Postoperative nausea and vomiting

    Time frame: Postoperative 6, 24, 48, and 72 hours.

    Record the number of patients who experienced postoperative nausea and vomiting (PONV).

  6. Number of Participants With Postoperative Pulmonary Complications (PPCs)

    Time frame: Within 72 hours postoperatively

    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.

  7. Length of Postoperative Hospital Stay

    Time frame: From the end of surgery until the date of hospital discharge, assessed up to 30 days postoperatively

    Time from the end of surgery to hospital discharge

  8. Train-of-Four Stimulation

    Time frame: At the end of surgery, 1 hour after the end of surgery.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shiyou Wei, PhD

CONTACT

[email protected]

8615601680288

Xin Lv, PhD

CONTACT

[email protected]

8618852869700

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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