Sugammadex versus neostigmine for early lung function recovery after thoracoscopic segmentectomy

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

This trial will test whether giving sugammadex instead of neostigmine helps adults having small thoracoscopic lung resections recover breathing function faster after surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (other)
• Locations: 3 sites (Shanghai, Shanghai Municipality and 2 other locations)
• Trial ID: NCT07309393 on ClinicalTrials.gov

What this trial studies

In a multicenter, randomized, double-blind trial, 240 adults (ASA I–III) undergoing elective unilateral thoracoscopic lung segmentectomy (≤1 segment) will be assigned 1:1 to receive either sugammadex (2 mg/kg) or neostigmine (0.03 mg/kg) plus atropine (0.015 mg/kg) at the end of surgery. Pulmonary function will be measured with a portable spirometer before surgery and at 1 hour post-extubation and on postoperative days 1–3, with the primary endpoint being percent decline in FEV1 at 1 hour versus baseline. Secondary outcomes include FEV1 over days 1–3, pain scores, opioid use, pulmonary complications, and PACU/hospital recovery metrics. The study tests the hypothesis that sugammadex leads to at least a 5% smaller decline in FEV1 at 1 hour compared with neostigmine.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–80 with ASA physical status I–III who are scheduled for elective unilateral thoracoscopic segmentectomy of one segment or less and who can perform portable spirometry.

Not a fit: Patients with significant hepatic or renal insufficiency, pregnancy or lactation, contraindications or allergies to the study drugs, inability to perform spirometry, use of depolarizing muscle relaxants, or those undergoing larger or repeat surgeries are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, sugammadex could reduce early postoperative loss of lung function and lower short-term respiratory complications after thoracoscopic lung resection.

How similar studies have performed: Previous trials have shown sugammadex provides faster and more complete reversal of rocuronium than neostigmine and improves recovery metrics, but evidence specifically linking sugammadex to improved early postoperative FEV1 after thoracoscopic lung resection is limited.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality and 2 other locations

• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
• Shanghai East Hospital,Affiliated to Tongji University — Shanghai, Shanghai Municipality, China (RECRUITING)
• Fudan university Shanghai cancer center — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Shiyou Wei, PhD

Conditions: Residual Neuromuscular Block, Sugammadex, Neostigmine, Forced Expiratory Volume, Lung Resection, Quality of Recovery