Clinical trial

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

Name
KY-2023-112
Description
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.
Trial arms
Trial start
2024-05-01
Estimated PCD
2025-01-31
Trial end
2025-08-31
Status
Not yet recruiting
Treatment
SUGAMMADEX SODIUM 100 Mg in 1 mL
The dose of Sugammadex Sodium 100 Mg in 1 mL is 2mg/kg
Arms:
Sugammadex Sodium group
Other names:
Sugammadex Sodium
Neostigmine
Neostigmine is 50 μg/kg
Arms:
Neostigmine group
Size
80
Primary endpoint
Muscle relaxation recovery time
Usually from half an hour to several hours(depending on the length of the procedure)
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2024-03-28

1 organization

2 products

1 indication

Product
Sugammadex