Comparative Efficacy and Safety of Sugammadex and Neostigmine

NCT04997759 | Unknown

• 1 other identifier: 202100679A3
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Along with unconsciousness and analgesia, use a muscle relaxant (Neuromuscular blocking agent NMBA) is now part of the classic triad of anesthesia. In surgery or interventional procedure under general anesthesia, NMBA is needed to relax the muscles of the whole body. Its purpose is to assist the placement of the endotracheal tube, avoid the participant's injury due to involuntary movements, and also enables the surgeon to have a better surgical vision, etc. Once the operation or procedure is completed, anesthesiologist will reverse the NMBA and participants are recovered from general anesthesia. It is crucial to maintain hemodynamic stability during this period. The participant's vital signs are unstable during this period because the participant is gradually recovered from anesthesia and they feel throat discomfort from endotracheal tube. Immediate extubation is encouraged in the operating theatre and full recovery of neuromuscular function must be achieved prior to extubation of the endotrachea tube. Traditionally, acetylcholinesterase inhibitor (AChEI, such as neostigmine, pyridostigmine, edrophonium) is used to reverse the efficacy of NMBA and stabilize the participants's vital signs. However, the reversal of acetylcholine ester inhibitors is slow, the curative effect has a ceiling effect, and the need to use anticholinergics (anticholinergics) to reduce the incidence of adverse reactions and other issues. In addition, traditional muscle relaxants may also cause complications, such as postoperative residual curarization (PORC). PORC is associated with weakness of upper airway muscles and increased risk of hypoventilation and hypoxemia, as well as risk for aspiration and postoperative pulmonary complications. Sugammadex is a new selective relaxant-binding agent that quickly and effectively reverses the effects of steroidal NMBAs, especially rocuronium and vecuronium. Compared with neostigmine, sugammadex more substantially reduces PORC, but its effects on postoperative complications require further investigation. Therefore, this study aimed to compare the effects of sugammadex and neostigmine during emergence and extubation after general anesthesia in non-cardiac surgery and interventional procedure.

Conditions

Sugammadex

Keywords

Neostigmine

Outcome Measures

Primary Outcomes (3)

• Extubation time

  Compare both group of extubation time and administer neostigmine or sugammadex

  Since administer neostigmine or sugammadex to 30mins after Extubation

• Blood pressure variability(systolic , diastolic and mean blood pressure)

  Compare both group of blood pressure variability and administer neostigmine or sugammadex

  Since administer neostigmine or sugammadex to 30mins after Extubation

• Heart rate variability

  Compare both group of heart rate variability and administer neostigmine or sugammadex

  Since administer neostigmine or sugammadex to 30mins after Extubation

Study Arms (2)

Neostigmine group

EXPERIMENTAL

This group will administered neostigmine for reverse the efficacy of neuromuscular blocking agent and stabilize the patient's vital signs.

Drug: Neostigmine and Sugammadex

Sugammadex group

EXPERIMENTAL

This group will administered Sugammadex for reverse the efficacy of neuromuscular blocking agent and stabilize the patient's vital signs.

Drug: Neostigmine and Sugammadex

Interventions

Neostigmine and Sugammadex DRUG

Compare both groups efficacy of reverse the neuromuscular blocking agent

Neostigmine group; Sugammadex group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>20year-old
• Go Intervention or operation under general anesthesia

You may not qualify if:

• Chronic kidney disease(GFR\<30 mL/min)
• Allergy to Sugammade/Neostigmine
• Cant extubate on the day of operation/intervention
• Neuromuscular disease
• Difficult airway
• Heart operation

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Yu-Hsun-Tsai

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Interventions

Neostigmine; Sugammadex

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 10, 2021
• Study Start: September 6, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2023
• Last Updated: March 10, 2022

Record last verified: 2021-07

Locations

TW (1)