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

Study Overview
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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.

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.

Official Title
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Comparison of Sugammadex and Sugammadex-neostigmine Combination in the Antagonism of Moderate Neuromuscular Block Induced by Rocuronium: A Prospective Randomized Cotrolled Study

Conditions
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Residual Neuromuscular Block, Neuromuscular Blockade Monitoring

Intervention / Treatment
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* Diagnostic Test: Neuromuscular monitoring
* Other: reverse of NMB with sugammadex
* Other: reverse of NMB with Sugammadex and neostigmin low dose
* Other: reverse of NMB with Sugammadex and neostigmin high dose


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized controlled double blind study
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group S<br>Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2. | Diagnostic Test: Neuromuscular monitoring<br>* TOF monitoring<br>Other: reverse of NMB with sugammadex<br>* Patients reversed with Sugammadex 2mg/kg after TOF count is 1-2.<br>|
| Active Comparator: Group SN1<br>Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2. | Diagnostic Test: Neuromuscular monitoring<br>* TOF monitoring<br>Other: reverse of NMB with Sugammadex and neostigmin low dose<br>* Patients reversed with Sugammadex 1mg/kg + Neostigmin 0.02 mg/kg<br>|
| Active Comparator: Grup SN2<br>Patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg after TOF count is 1-2. | Diagnostic Test: Neuromuscular monitoring<br>* TOF monitoring<br>Other: reverse of NMB with Sugammadex and neostigmin high dose<br>* patients reversed with sugammadex 1.5 mg/kg + Neostigmin 0.02 mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual curarization rate | Pecents of Patients TOFR<0.9 | through study completion an average of 3 months | 
| SPO2 | peripheric oxygen saturation | through study completion an average of 3 months | 
| MAP | Mean arterial pressure | through study completion an average of 3 months | 
| HR | Heart Rate | through study completion an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PONV | Postoperative nausea and vomiting | through study completion an average of 3 months | 
| Time to Return of bowel movements | when patients' bowel movements return | through study completion an average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sugammadex, Neostigmine, Neuromuscular Blockade Monitoring, Postoperative Nausea and Vomiting, Delayed Emergence from Anesthesia, Postoperative Complications, Rocuronium, Residual Neuromuscular Block