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

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06334562
• Other study ID #: KY-2023-112
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2024
• Source: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Contact: JianHong Xu
• Phone: 86-18867961109
• Email: xujh1969[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• SUGAMMADEX SODIUM 100 Mg in 1 mL
The dose of Sugammadex Sodium 100 Mg in 1 mL is 2mg/kg
• Neostigmine
Neostigmine is 50 µg/kg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle relaxation recovery time	The time from using antagonists to TOFr recovery to 0.9	Usually from half an hour to several hours(depending on the length of the procedure)