Comparative Efficacy and Safety of Sugammadex and Neostigmine

Sugammadex Clinical Trial

Official title:

The Comparative Efficacy and Safety of Sugammadex and Neostigmine in Reversing Neuromuscular Blockade After General Anesthesia: A Prospective Randomized Control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04997759
• Other study ID #: 202100679A3
• Status: Recruiting
• Phase: N/A
• Start date: September 6, 2021
• Est. completion date: August 30, 2023

Study information

• Verified date: July 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sugammadex

Intervention

Drug:
• Neostigmine and Sugammadex
Compare both groups efficacy of reverse the neuromuscular blocking agent

Locations

Country	Name	City	State
Taiwan	Yu-Hsun-Tsai	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extubation time	Compare both group of extubation time and administer neostigmine or sugammadex	Since administer neostigmine or sugammadex to 30mins after Extubation
Primary	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
Primary	Heart rate variability	Compare both group of heart rate variability and administer neostigmine or sugammadex	Since administer neostigmine or sugammadex to 30mins after Extubation