Residual Neuromuscular BlockNCT07309393
Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function
A study testing Sugammadex and Neostigmine in people with Residual Neuromuscular Block, run by Shanghai Pulmonary Hospital, Shanghai, China at 3 sites in China.
Trial summary
Residual neuromuscular blockade (NMB) after general anesthesia increases the risk of postoperative respiratory complications (atelectasis, pneumonia, re-intubation) and delays pulmonary function recovery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Residual Neuromuscular Block
- What is being tested?
- Sugammadex and Neostigmine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesChina
- Study dates
- 30 Dec 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200082
Shiyou Wei, MD, 86-021-65115006 ext. 2260, lovewishyou@163.com
Jiong Song, MD, 86-15601680288, sw480@126.com
- Recruiting
Shanghai East Hospital,Affiliated to Tongji University
Shanghai, Shanghai Municipality, 200120
Jie Wu, MD., 8613262702619, wujie20156@hotmail.com
- Recruiting
Fudan university Shanghai cancer center
Shanghai, Shanghai Municipality
Dandan Ling, 0216417559001, lddyue@163.com
Jun Zhang, 0216417559001-1066
About this study
Official title: Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function After Thoracoscopic Lung Resection: A Multicenter, Randomized, Double-Blind, Controlled 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.
Read the detailed description
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.
- Conditions
- Residual Neuromuscular Block
- Being tested
- Sugammadex, Neostigmine
- Keywords
- Sugammadex, Neostigmine, Forced Expiratory Volume (FEV1), Lung Resection, Quality of Recovery
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
Also called HengShu, Sugammadex sodium
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).
NeostigmineDrug
Also called Neostigmine methylsulfate
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Neostigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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).
Measured: Postoperative 1 hour and postoperative day 1-3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start30 Dec 2025
- Primary completion25 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residual Neuromuscular BlockStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyou Wei, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Xin Lv, PhD, Study director, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309393
- Sponsor's protocol ID
- 2025LY0107
- Status last verified
- Jun 2026
- First submitted
- 3 Aug 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function After Thoracoscopic Lung Resection: A Multicenter, Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT07309393
- Acronym / sponsor ID
- 2025LY0107
- Conditions
- Residual Neuromuscular Block
- Keywords
- Sugammadex, Neostigmine, Forced Expiratory Volume (FEV1), Lung Resection, Quality of Recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 25 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sugammadex Group | Experimental | Drug: SugammadexParticipants 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. |
| Neostigmine Group | Active comparator | Drug: NeostigmineParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugammadexAlso: HengShu, Sugammadex sodiumSugammadex 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). | Drug | Sugammadex Group |
| NeostigmineAlso: Neostigmine methylsulfateNeostigmine (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). | Drug | Neostigmine Group |
Primary outcome
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.
2 secondary outcomes
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.
Postoperative Pain Score
Time frame: Postoperative 1 hour and postoperative day 1-3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xin Lv, PhD study director
Shanghai Pulmonary Hospital, Tongji University, Shanghai, China
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugammadex and Neostigmine in people with Residual Neuromuscular Block, run by Shanghai Pulmonary Hospital, Shanghai, China at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shiyou Wei, PhD (8615601680288, lovewishyou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.