Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Pulmonary Hospital, Shanghai, China

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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).

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Sugammadex GroupExperimental treatment 1 intervention
Group B: Neostigmine GroupActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.
2

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.

Other outcomes

1

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).
2

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.
3

Gastrointestinal Function Recovery

The time to first postoperative gastrointestinal flatus

Time frame
Postoperative day 1-3.
4

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.