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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Residual Neuromuscular Block Neuromuscular Blockade Monitoring

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled double blind study

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group S

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

Group Type ACTIVE_COMPARATOR

Neuromuscular monitoring

Intervention Type DIAGNOSTIC_TEST

TOF monitoring

reverse of NMB with sugammadex

Intervention Type OTHER

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

Group SN1

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

Group Type ACTIVE_COMPARATOR

Neuromuscular monitoring

Intervention Type DIAGNOSTIC_TEST

TOF monitoring

reverse of NMB with Sugammadex and neostigmin low dose

Intervention Type OTHER

Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg

Grup SN2

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

Group Type ACTIVE_COMPARATOR

Neuromuscular monitoring

Intervention Type DIAGNOSTIC_TEST

TOF monitoring

reverse of NMB with Sugammadex and neostigmin high dose

Intervention Type OTHER

patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg

Interventions

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Neuromuscular monitoring

TOF monitoring

Intervention Type DIAGNOSTIC_TEST

reverse of NMB with sugammadex

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

Intervention Type OTHER

reverse of NMB with Sugammadex and neostigmin low dose

Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg

Intervention Type OTHER

reverse of NMB with Sugammadex and neostigmin high dose

patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No