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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex Injection [Bridion] | Experimental | reversal of neuromuscular blockade with sugammadex |
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| Neostigmine+Glycopyrronium | Active Comparator | reversal of neuromuscular blockade with neostigmine & glycopyrrolate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex Injection [Bridion] | Drug | Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe. |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tae-Kyun Kim, MD, PhD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19194156 | Background | Plaud B, Meretoja O, Hofmockel R, Raft J, Stoddart PA, van Kuijk JH, Hermens Y, Mirakhur RK. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009 Feb;110(2):284-94. doi: 10.1097/ALN.0b013e318194caaa. | |
| 23043512 | Background | Locatelli BG, Ingelmo PM, Emre S, Meroni V, Minardi C, Frawley G, Benigni A, Di Marco S, Spotti A, Busi I, Sonzogni V. Emergence delirium in children: a comparison of sevoflurane and desflurane anesthesia using the Paediatric Anesthesia Emergence Delirium scale. Paediatr Anaesth. 2013 Apr;23(4):301-8. doi: 10.1111/pan.12038. Epub 2012 Oct 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sugammadex | reversal of neuromuscular blockade with sugammadex Sugammadex Injection [Bridion]: Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe. |
| FG001 | Neostigmine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 11, 2017 |
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| Neostigmine+Glycopyrronium | Drug | 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. |
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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 |
| 20735801 | Background | Pieters BJ, Penn E, Nicklaus P, Bruegger D, Mehta B, Weatherly R. Emergence delirium and postoperative pain in children undergoing adenotonsillectomy: a comparison of propofol vs sevoflurane anesthesia. Paediatr Anaesth. 2010 Oct;20(10):944-50. doi: 10.1111/j.1460-9592.2010.03394.x. Epub 2010 Aug 24. |
reversal of neuromuscular blockade with neostigmine & glycopyrrolate Neostigmine+Glycopyrronium: 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. |
| COMPLETED |
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| NOT COMPLETED |
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One patient in Neostigmine group was dropped for the violation of protocol.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sugammadex | reversal of neuromuscular blockade with sugammadex Sugammadex Injection [Bridion]: Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe. |
| BG001 | Neostigmine | reversal of neuromuscular blockade with neostigmine & glycopyrrolate Neostigmine+Glycopyrronium: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Full Range | units on a scale | within 30 minutes after arrival at post-anesthesia care unit (PACU) |
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| Secondary | 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 | Posted | Mean | Standard Deviation | seconds | Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7, assessed up to 60 minutes |
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| Secondary | Time to Regular Breathing | time from administration of reversal agent to time of deep, regular breathing | Posted | Mean | Standard Deviation | seconds | time from administration of reversal agent to time of deep, regular breathing, assessed up to 60 minutes |
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| Secondary | Time to Awakening | time from administration of reversal agent to time of eye opening or child showing purposeful movement | Posted | Mean | Standard Deviation | seconds | time from administration of reversal agent to time of eye opening or child showing purposeful movements, assessed up to 60 minutes |
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| Secondary | Time to Extubation | time from administration of reversal agent to time of tracheal extubation | Posted | Mean | Standard Deviation | seconds | time from administration of reversal agent to time of tracheal extubation, assessed up to 60 minutes |
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| Secondary | 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 | Posted | Mean | Standard Deviation | seconds | Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.8, assessed up to 60 minutes |
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| Secondary | 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 | Posted | Mean | Standard Deviation | seconds | Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9, assessed up to 60 minutes |
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Anaphylaxis, bradycardia, vomiting, pain, nausea, hypotension, and headache are monitored at post-anesthetic care unit until the patients discharge. It took 1 hour after administration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sugammadex | reversal of neuromuscular blockade with sugammadex Sugammadex Injection [Bridion]: Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG001 | Neostigmine | reversal of neuromuscular blockade with neostigmine & glycopyrrolate Neostigmine+Glycopyrronium: 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor | Pusan National University Yangsan Hospital | 0553602756 | anesktk@pusan.ac.kr |
| Feb 19, 2020 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003912 | Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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