Neuromuscular Blockade Reversal Agent Effect on Postoperative Cognitive Function and Behaviour in Children

Study Overview
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Brief Summary
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The aim of this prospective randomized study is to investigate comparatively the effect of neostigmine-atropine versus sugammadex on speed and quality of recovery and on postoperative cognitive function & behavior in children undergoing ENT surgery under general anaesthesia.

Detailed Description
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The aim of this prospective randomized study is to investigate comparatively the effect of neostigmine-atropine vs sugammadex on time of achieving extubation, quality of recovery, postoperative cognitive function and behaviour of children undergoing ENT surgery under general anaesthesia. In this study after parental approval has been obtained, children with age 6-12 yrs undergoing tonsillectomy and/or adenoidectomy under general anaesthesia will be included. General anaesthesia will be performed using Total Intravenous Anaesthesia (TIVA) technique with continuous infusion of propofol and remifentanil. Rocuronium will be used to achieve neuromuscular blockade (NMB). Neuromuscular reversal will be performed using either atropine-neostigmine or sugammadex. Patients will be divided into 2 groups according to the type of NMB reversal agent used. Intraoperative monitoring will include Bispectral Index Sedation (BIS), SpO2, capnography, noninvasive measurements of blood pressure, heart rate and train of four (TOF). Children will be assessed preoperatively (one day before surgery and at the morning of day of surgery), intraoperatively, immediate postoperatively and will be followed up for 15 postoperative days. Additionally, parents will be cooperated and questioned. The primary end-points of the study include the comparative investigation of the effect of neostigmine-atropine vs sugammadex on time of achieving extubation, quality of recovery, and postoperative cognitive function of children. Secondary endpoints will include side effects, signs of residual neuromuscular blockade, agitation and postoperative behavioural changes of children. For this purpose the following scales and questionnaires will be used: Emotionality, Activity, Sociability & Impulsivity (EASI) Scale The Modified Mini-Mental State (3MS) Test - Version G Greek Yale Preoperative Anxiety Scale Aldrete score Emergence Delirium (PAED) scale Wong-Baker scale Visual Analogue Scale (VAS) (0-10) Child Post- Hospital Behavior Questionnaire (PHBQ)] Post discharge repeated questionnaire All the questionnaires will be translated, culturally adapted and validated in Greek. Analysis of the data will include pair wise T test in order to find statistical differences between the two techniques and regression analysis models in order to revile significant correlations between dependent and independent variables. Statistical analysis will be performed with the use of SPSS21 for Windows.

Official Title
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Comparative Effect of Neuromuscular Blockade Reversal Agent on Extubation Conditions, Postoperative Cognitive Function and Behaviour of School-aged Children Undergoing Ear Note Throat (ENT) Surgery

Conditions
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Anesthesia; Functional

Intervention / Treatment
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* Drug: neostigmine - atropine
* Drug: Sugammadex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Children undergoing ENT surgery under general anaesthesia. Exclusion Criteria: Parents refusal Cognitive impairment Difficulty in communication due to language issues Psychiatric disorder Severe systematic disorder Known allergy to any drug used

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sugammadex<br>iv sugammadex 2 mg/Kg | Drug: Sugammadex<br>* Efficacy, safety and effect on cognitive and behavioural function<br>* Other names: Bridion;|
| Active Comparator: neostigmine - atropine<br>iv neostigmine 0,05 mg/Kg - atropine 0,02 mg/kg Efficacy, safety and effect on cognitive and behavioural function | Drug: neostigmine - atropine<br>* Efficacy, safety and effect on cognitive and behavioural function<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of achieving extubation | time of achieving extubation | 10 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| signs of residual neuromuscular blockade | number of participants with signs of residual | 1 hour | 
| Behavioural function | changes using Battery test | up to 15th postoperative day |