Comparative Efficacy and Safety of Sugammadex and Neostigmine

NCT ID: NCT04997759

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-06
• Study Completion Date: 2023-08-30

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.

Detailed Description

Investigators will include 100 participants for both groups(Suggammadex and Neostigmine) During anesthesia induction, the same drugs will be administered intravenously (propofol, fentanyl, lidocaine and rocuronium). Rocuronium, a muscle relaxant,is 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 participants injury due to involuntary movements, and also enables the surgeon to have a better surgical vision, etc. Once the operation or procedure is completed, Investigators will reverse the NMBA and participants are recovered from general anesthesia. Group A will be administered acetylcholinesterase inhibitor (AChEI, such as neostigmine, pyridostigmine, edrophonium), AChEI is used to reverse the efficacy of NMBA and stabilize the participants's vital signs. Group B will be administered sugammadex, a new selective relaxant-binding agent that quickly and effectively reverses the effects of steroidal NMBAs. Both drug should given on the time of train of four[TOF] count 4. Investigators will collect the data include: Blood pressure(extubation, one minute, two minutes and five minutes and ten minutes after), Heart rate, Saturation, extubation time and BIS.

Conditions

Sugammadex

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neostigmine group

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

Group Type: EXPERIMENTAL

Neostigmine and Sugammadex

Intervention Type: DRUG

Compare both groups efficacy of reverse the neuromuscular blocking agent

Sugammadex group

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

Group Type: EXPERIMENTAL

Neostigmine and Sugammadex

Intervention Type: DRUG

Compare both groups efficacy of reverse the neuromuscular blocking agent

Interventions

Neostigmine and Sugammadex

Compare both groups efficacy of reverse the neuromuscular blocking agent

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yu-Hsun-Tsai

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

YU HUSN TSAI

Role: primary

evan468579@hotmail.com

886-928218752

Other Identifiers

202100679A3

Identifier Type: -

Identifier Source: org_study_id