Comparison of Sugammadex and Sugammadex-neostigmine Combination in the Antagonism of Moderate Neuromuscular Block

Ankara City Hospital

Status: Unknown

Conditions: Neuromuscular Blockade Monitoring; Residual Neuromuscular Block

Treatments: Diagnostic Test: Neuromuscular monitoring; Other: reverse of NMB with Sugammadex and neostigmin high dose; Other: reverse of NMB with sugammadex; Other: reverse of NMB with Sugammadex and neostigmin low dose

Study type: Interventional

Funder types: Other

Identifiers

NCT05228223

E1-21-1914

Details and patient eligibility

About

In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.

Full description

Sugammadex is a novel drug used to reverse neuromuscular blockade. It shows its effect by binding with steroid neuromuscular agents at a ratio of 1:1. Compared to anticholinesterase and other neuromuscular reverse agents, sugammadex shows less cholinergic side effects and less residual muscle relaxation. Besides all these, sugammadex reverses neuromuscular blockade very quickly. In addition to these benefits, it has side effects such as hypersensitivity and this side effect can be seen more at high doses. In addition, sugammadex is more costly than other neuromuscular reverse agents.

In this prospective randomized controlled study the investigators compare the sugammadex-neostigmine combination and single dose sugammadex in terms of side effects and cost for the antagonism of moderate neuromuscular block induced by rocuronium.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective general anesthesia
• Female gender
• Between the ages of 18-65

Exclusion criteria

• ASA ≥ 3
• Pregnancy
• Contraindication to use of anesthetic drugs
• Kidney failure
• Liver failure
• Heart failure
• BMI <18 and BMI > 35 kg/m2
• anticipated difficult airway
• neuromuscular disease
• Use of drugs that impair neuromuscular transmission
• Patients who develop unexpected massive hemorrhage
• Those who do not have the ability to read, understand and sign the consent form
• Refusal of patient

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Group S

Active Comparator group

Description:

Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2.

Treatment:

Diagnostic Test: Neuromuscular monitoring

Other: reverse of NMB with sugammadex

Group SN1

Active Comparator group

Description:

Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2.

Treatment:

Diagnostic Test: Neuromuscular monitoring

Other: reverse of NMB with Sugammadex and neostigmin low dose

Grup SN2

Active Comparator group

Description:

Patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2.

Treatment:

Other: reverse of NMB with Sugammadex and neostigmin high dose

Diagnostic Test: Neuromuscular monitoring