An interventional study of Sugammadex and Neostigmine in Residual Neuromuscular Block, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Recruiting at 3 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Not applicable, Interventional, and Treatment
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.
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.
98 studies on the registry are indexed under Delayed Emergence from Anesthesia; 17 are open to participants now.
This study's planned enrollment of 240 is above the median of 83 across 58 interventional studies indexed under Delayed Emergence from Anesthesia.
Browse Delayed Emergence from Anesthesia studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 160 studies on the registry; 95 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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).
Also known as: HengShu, Sugammadex sodium
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).
Also known as: Neostigmine methylsulfate
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.
Time frame: Preoperative (baseline, within 7 days before surgery) and 1 hour postoperative.
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.
Time frame: 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).
Time frame: Postoperative 1 hour and postoperative day 1-3.
Cumulative Opioid Consumption
Total cumulative opioid dosage (in morphine equivalents) administered postoperatively, including patient-controlled analgesia and rescue doses .
Time frame: 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.
Time frame: At the end of surgery and 1 hour postoperative.
Gastrointestinal Function Recovery
The time to first postoperative gastrointestinal flatus
Time frame: 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.
Time frame: Postoperative day 1-3
Postoperative nausea and vomiting
Record the number of patients who experienced postoperative nausea and vomiting (PONV).
Time frame: 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.
Time frame: Within 72 hours postoperatively
Length of Postoperative Hospital Stay
Time from the end of surgery to hospital discharge
Time frame: 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.
Time frame: At the end of surgery, 1 hour after the end of surgery.
Plan to share: No
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Started Dec 2025 (actual). Primary completion is estimated for Sep 2026, 8 months after the start.
Of 20 interventional studies with no phase under Delayed Emergence from Anesthesia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 17. This study's planned 8 months is below that.
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Studies of the drug tested here: Sugammadex
Delayed Emergence from Anesthesia →
Shanghai Pulmonary Hospital, Shanghai, China →