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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Drug: SUGAMMADEX SODIUM 100 Mg in 1 mL; Drug: Neostigmine

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: JianHong Xu; Phone Number: 86-18867961109; Email: xujh1969@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sugammadex Sodium group; The dose of Sugammadex Sodium is 2mg/kg	Drug: SUGAMMADEX SODIUM 100 Mg in 1 mL; The dose of Sugammadex Sodium 100 Mg in 1 mL is 2mg/kg; Other Names: Sugammadex Sodium
Active Comparator: Neostigmine group; The dose of Neostigmine is 50 μg/kg	Drug: Neostigmine; Neostigmine is 50 μg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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）

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Investigators: Principal Investigator: JianHong Xu, The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: thoracic surgery; Sugammadex Sodium; Postoperative Neuromuscular Block Antagonism
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: KY-2023-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No