Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function

NCT07309393 | Recruiting DMC

• 1 other identifier: 2025LY0107
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Residual Neuromuscular Block

Keywords

Sugammadex; Neostigmine; Forced Expiratory Volume (FEV1); Lung Resection; Quality of Recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

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

• Postoperative Pain Score

  Postoperative 1 hour and postoperative day 1-3.

Other Outcomes (8)

• Cumulative Opioid Consumption

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

• Neuromuscular Recovery (TOF Ratio)

  At the end of surgery and 1 hour postoperative.

• Gastrointestinal Function Recovery

  Postoperative day 1-3.

Study Arms (2)

Sugammadex Group

EXPERIMENTAL

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

Neostigmine Group

ACTIVE COMPARATOR

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

Interventions

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).

Also known as: HengShu, Sugammadex sodium

Sugammadex Group

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).

Also known as: Neostigmine methylsulfate

Neostigmine Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (3)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200082, China

RECRUITING

Shanghai East Hospital,Affiliated to Tongji University

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

Fudan university Shanghai cancer center

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Xin Lv, PhD

  Shanghai Pulmonary Hospital, Tongji University, Shanghai, China

  STUDY DIRECTOR

Central Study Contacts

Shiyou Wei, PhD

CONTACT

8615601680288; lovewishyou@163.com

Xin Lv, PhD

CONTACT

8618852869700; xinlvg@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind masking is implemented for participants and investigators to minimize bias. At the end of surgery, an independent anesthesia nurse prepares the study drug (sugammadex 2 mg/kg or neostigmine 0.03 mg/kg plus atropine 0.015 mg/kg) diluted in normal saline to a total volume of 10 mL in identical syringes, ensuring that the administering anesthesiologist and other study personnel remain blinded to the group assignment. Participants are also unaware of the assigned reversal agent. Blinding is maintained throughout the postoperative follow-up period, with unblinding reserved for emergencies or serious adverse events as per protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology

Model Details: This is a multicenter, randomized, double-blind, controlled trial with parallel group assignment. Eligible patients undergoing unilateral thoracoscopic lung segmentectomy (not exceeding one lung segment) are randomized in a 1:1 ratio to receive either sugammadex (experimental group) or neostigmine plus atropine (control group) for reversal of rocuronium-induced neuromuscular blockade at the end of surgery. The primary focus is on comparing the effects on early postoperative pulmonary function recovery, with assessments conducted preoperatively and at postoperative 1 hour, 1-3 days, or before discharge.

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: December 30, 2025
• Study Start: December 31, 2025
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)