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NCT Number: NCT06334562

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

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.

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

Location status: Recruiting

Location contact

jianhong xu

CONTACT

[email protected]

+86 18757870947

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • The patient explicitly refused to participate in this trial;
  • 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;
  • Patients with tracheal malformations or suspected difficult airways, coagulation dysfunction, severe liver and kidney dysfunction, and severe lung disease;
  • Patients who are not extubated and sent to the ward or ICU after surgery;
  • The researchers believe that patients with any other unfavorable factors to participate in this trial.

Treatment and study plan

SUGAMMADEX SODIUM 100 Mg in 1 mL

Drug

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

Other names: Sugammadex Sodium

Neostigmine

Drug

Neostigmine is 50 μg/kg

Primary outcomes

  1. Muscle relaxation recovery time

    Time frame: Usually 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

Study contacts

Contact information is provided by the study sponsor or research team.

JianHong Xu

CONTACT

[email protected]

86-18867961109

Sponsors and collaborators

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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