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

NCT06334562 | Recruiting

• 1 other identifier: KY-2023-112
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuromuscular Blockade

Keywords

Sugammadex Sodium; Postoperative Neuromuscular Block Antagonism; thoracic surgery

Outcome Measures

Primary Outcomes (1)

• 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）

Study Arms (2)

Sugammadex Sodium group

EXPERIMENTAL

The dose of Sugammadex Sodium is 2mg/kg

Drug: SUGAMMADEX SODIUM 100 Mg in 1 mL

Neostigmine group

ACTIVE COMPARATOR

The dose of Neostigmine is 50 μg/kg

Drug: Neostigmine

Interventions

SUGAMMADEX SODIUM 100 Mg in 1 mL DRUG

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

Also known as: Sugammadex Sodium

Sugammadex Sodium group

Neostigmine DRUG

Neostigmine is 50 μg/kg

Neostigmine group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

MeSH Terms

Interventions

Sugammadex; Neostigmine

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• JianHong Xu

  The Fourth Affiliated Hospital of Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JianHong Xu

CONTACT

86-18867961109; xujh1969@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 28, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)