Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of sugammadex vs. a conventional acetylcholinesterase inhibitor, neostigmine on emergence delirium (ED) during sevoflurane-rocuronium anesthesia in pediatric patients Additionally, the efficacy features of sugammadex compared to neostigmine will be examined by measuring the time from start of administration of reversal agents to recovery of train-of-four (TOF) ratio to 0.7, 0.8, and 0.9. Although the etiology of ED remains unclear, a sense of suffocation or breathing difficulty during emergence from anesthesia has been suggested as a possible cause. Thus, reversal of neuromuscular blockade with sugammadex in pediatric patients maintained with sevoflurane-rocuronium anesthesia may decrease ED due to its faster reversal of neuromuscular blockade and decreased possibility of residual blockade.

Detailed Description
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Emergence delirium (ED) is a postanesthetic phenomenon that develops in the early phase of general anesthesia recovery, (usually within the first 30 minutes,) and is defined as a disturbance in a child's awareness of and attention to his/her environment with disorientation and perceptual alterations including hypersensitivity to stimuli and hyperactive motor behavior . Children are often irritable, uncompromising, uncooperative, incoherent, and inconsolably crying, moaning, kicking, or thrashing. The incidence of ED varies from 2 to 80%, occurring more frequently in preschool boys. Risk factors also include the following: sevoflurane or desflurane anesthesia; ear, nose and throat surgery; preoperative anxiety. ED is known to increase physical, psychological, and financial burdens in the postanesthesia care unit, which emphasizes the importance of its prevention. The aim of this study is to investigate the effect of sugammadex vs. a conventional acetylcholinesterase inhibitor, neostigmine on emergence delirium (ED) during sevoflurane-rocuronium anesthesia in pediatric patients Additionally, the efficacy features of sugammadex compared to neostigmine will be examined by measuring the time from start of administration of reversal agents to recovery of TOF ratio to 0.7, 0.8, and 0.9. Although the etiology of ED remains unclear, a sense of suffocation or breathing difficulty during emergence from anesthesia has been suggested as a possible cause. Thus, reversal of neuromuscular blockade with sugammadex in pediatric patients maintained with sevoflurane-rocuronium anesthesia may decrease ED due to its faster reversal of neuromuscular blockade and decreased possibility of residual blockade.

Official Title
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A Prospective, Double-blind, Randomized Study to Investigate the Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Emergence Delirium During Sevoflurane-rocuronium Anesthesia in Pediatric Patients

Conditions
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Emergence Delirium

Intervention / Treatment
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* Drug: Sugammadex Injection [Bridion]
* Drug: Neostigmine+Glycopyrronium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist (ASA) physical status I or II, preschool children scheduled for an elective tonsillectomy with or without adenoidectomy will be included in the study. Exclusion Criteria: Patients will be excluded in cases of emergency surgery, developmental, psychological, cognitive or communication disorders, known or suspected neuromuscular disorders that may impair neuromuscular blockade, significant renal or hepatic dysfunction, coagulation disorders, family history of malignant hyperthermia, allergy to any of the drugs included in the study protocol, or usage of medication known to interact with rocuronium or sugammadex.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex Injection [Bridion]<br>reversal of neuromuscular blockade with sugammadex | Drug: Sugammadex Injection [Bridion]<br>* Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe.<br>* Other names: Sugammadex;|
| Active Comparator: Neostigmine+Glycopyrronium<br>reversal of neuromuscular blockade with neostigmine & glycopyrrolate | Drug: Neostigmine+Glycopyrronium<br>* Return to T2 point (two contractions) on TOF device is replied by iv 0.06 mg/kg neostigmine and 0.005 mg/kg glycopyrrolate administration, contained in a blinded syringe.<br>* Other names: Neostigmine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pediatric Anesthesia Emergence Delirium Score | Maximum Pediatric Anesthesia Emergence Delirium (PAED) score after arrival in the PACU.Higher values represent more emergence delirium (worse) PAED Score is represented with total PAED score summed up of subscales. The total score is reported and it ranges from 0 to 20. Higher score means worse state. | within 30 minutes after arrival at post-anesthesia care unit (PACU) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Recovery of TOF Ratio to 0.7 | Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7 | Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7, assessed up to 60 minutes | 
| Time to Regular Breathing | time from administration of reversal agent to time of deep, regular breathing | time from administration of reversal agent to time of deep, regular breathing, assessed up to 60 minutes | 
| Time to Awakening | time from administration of reversal agent to time of eye opening or child showing purposeful movement | time from administration of reversal agent to time of eye opening or child showing purposeful movements, assessed up to 60 minutes | 
| Time to Extubation | time from administration of reversal agent to time of tracheal extubation | time from administration of reversal agent to time of tracheal extubation, assessed up to 60 minutes | 
| Time Recovery of TOF Ratio to 0.8 | Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.8 | Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.8, assessed up to 60 minutes | 
| Time Recovery of TOF Ratio to 0.9 | Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9 | Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9, assessed up to 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emergence delirium, tonsillectomy