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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Neuromuscular Blockade

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Sugammadex Sodium group

The dose of Sugammadex Sodium is 2mg/kg

Group Type EXPERIMENTAL

SUGAMMADEX SODIUM 100 Mg in 1 mL

Intervention Type DRUG

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

Neostigmine group

The dose of Neostigmine is 50 μg/kg

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

Neostigmine is 50 μg/kg

Interventions

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SUGAMMADEX SODIUM 100 Mg in 1 mL

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

Intervention Type DRUG

Neostigmine

Neostigmine is 50 μg/kg

Intervention Type DRUG

Other Intervention Names

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Sugammadex Sodium

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes