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The Clinical Effect of Sugammadex Sodium (Domestic) for Antagonizing Neuromuscular Blockade After Thoracic Surgery

An Observational Study on the Clinical Effect of Sugammadex Sodium (Domestic) for Antagonizing Neuromuscular Blockade After Thoracic Surgery

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06334562
Enrollment
80
Registered
2024-03-28
Start date
2024-06-01
Completion date
2025-12-31
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade

Keywords

Sugammadex Sodium, Postoperative Neuromuscular Block Antagonism, thoracic surgery

Brief summary

This study aims to compare the use of sugammadex (domestic) and neostigmine for antagonism after thoracic surgery, and observe the effect of sugammadex (domestic) on neuromuscular blockade antagonism after thoracic surgery, in order to provide a basis for optimizing the use of muscle relaxants and their antagonists during anesthesia.

Detailed description

All patients were well prepared preoperatively, and vital signs monitoring and accelerated muscle relaxation monitor and TOF monitoring of muscle relaxation were improved after admission. General anaesthesia was induced and maintained by an experienced anaesthesiologist according to the routine drug administration protocol. The neuromuscular blocking drug was limited to rocuronium bromide at an induction dose of 0.6 mg/kg. Anaesthesia was induced with intravenous propofol and maintained with sevoflurane, and rocuronium bromide 0.15 mg/kg. At the end of surgery when the patient's degree of neuromuscular blockade spontaneously recovered to T2 reappearance, the neuromuscular blocking effect of rocuronium bromide was reversed by intravenous rapid injection of sugammadex (domestic) injection or neostigmine within 10 s. The dose of sugammadex (domestic) was 2 mg/kg, and neostigmine 50 μg/kg. Information on dosage and time of neuromuscular blocking medication was recorded, and the patients were recorded at the end of the surgery. Neuromuscular function and clinical performance after reversal with sugammadex (domestic) at the end of the procedure, recording the recovery time of neuromuscular function, extubation time, and time of leaving the room.

Interventions

DRUGSUGAMMADEX SODIUM 100 Mg in 1 mL

The dose of Sugammadex Sodium 100 Mg in 1 mL is 2mg/kg

DRUGNeostigmine

Neostigmine is 50 μg/kg

Sponsors

The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

1. Patients who undergo elective lung surgery under general anesthesia and require endotracheal intubation; 2. Age\>18 years old, gender not limited; 3. American Society of Anesthesiologists ASA Level I-III; 4. Use rocuronium bromide for neuromuscular blockade; 5. The patient voluntarily participated in the trial.

Exclusion criteria

1. The patient explicitly refused to participate in this trial; 2. Family history of malignant hyperthermia, patients with allergies to sodium sulbactam, neostigmine ingredients and their excipients, and patients with allergies to drugs used during general anesthesia; 3. Patients with tracheal malformations or suspected difficult airways, coagulation dysfunction, severe liver and kidney dysfunction, and severe lung disease; 4. Patients who are not extubated and sent to the ward or ICU after surgery; 5. The researchers believe that patients with any other unfavorable factors to participate in this trial.

Design outcomes

Primary

MeasureTime frameDescription
Muscle relaxation recovery timeUsually from half an hour to several hours(depending on the length of the procedure)The time from using antagonists to TOFr recovery to 0.9

Countries

China

Contacts

Primary ContactJianHong Xu
xujh1969@163.com86-18867961109

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026