Sugammadex: Effect on the Awareness Monitoring and Hemodynamics

Study Overview
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Brief Summary
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Sugammadex is used to reverse the neuromuscular blocking effect of steroid neuromuscular blockers. Its cardiovascular effects and effect on brain cortex, if any, may be associated to the reversal of the neuromuscular block. The aim of the study was to investigate the pure effects of sugammadex in the absence of the agonist.

Detailed Description
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Three groups of patients undergoing elective major surgery and given cis-atracurium for muscle relaxation are studied. Group 1 receives 2 mg/kg of sugammadex when a count of two of the train of four appears Group 2 receives 4 mg/kg of sugammadex when a posttetanic count 1-3 appears Group 3 receives 16 mg/kg of sugammadex three minutes after administration of cis-atracurium. Heart rate, arterial blood pressure, oxygen saturation, end-tidal CO2, entropy and bispectral index are recorded every three minutes

Official Title
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The Effect of Sugammadex on Hemodynamics, Oxygenation, End-tidal CO2, Entropy and Bispectral Index Intraoperatively Without Steroid Neuromuscular Blocker

Conditions
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Surgical Procedure, Unspecified

Intervention / Treatment
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* Drug: sugammadex
* Drug: Sugammadex 4 mg/kg
* Drug: Sugammadex 16mg/kg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients ASA I-III scheduled for elective major surgery both sexes Exclusion Criteria: patients hypertensive treated with antihypertensive drugs

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sugammadex 2 mg/kg<br>2 mg/kg of sugammadex are given when a response of two counts of train of four are present | Drug: sugammadex<br>* Sugammadex 2 mg/kg when a two count of train of four appears<br>|
| Active Comparator: 4 mg/kg of sugammadex<br>4 mg/kg of sugammadex are given when a posttetanic count 1-3 appears | Drug: Sugammadex 4 mg/kg<br>* Sugammadex 4 mg/kg are given when a posttetanic count 1-3 appears<br>|
| Active Comparator: Sugammadex 16 mg/kg<br>Sugammadex 16 mg/kg are given three minutes after the injection of cis-atracurium | Drug: Sugammadex 16mg/kg<br>* Sugammadex 16 mg/kg three minutes after the injection of cis-atracurium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Entropy |  | every three minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamics |  | every three minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sugammadex, entropy, bispectral index, blood pressure, heart rate, oxygenation, end-tidal CO2, hemodynamics, general anesthesia