A Phase 4 interventional study of Sugammadex Injection [Bridion] and Neostigmine+Glycopyrronium in Emergence Delirium, sponsored by Pusan National University Yangsan Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 2 Years to 7 Years. Per ClinicalTrials.gov, last updated 2020-03-17.
Sponsored by Pusan National University Yangsan Hospital · Phase 4, Interventional, and 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 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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 40 is below the median of 120 across 599 interventional studies indexed under Delirium.
Browse Delirium studies →Pusan National University Yangsan Hospital is the lead sponsor of 106 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
reversal of neuromuscular blockade with sugammadex
Drug: Sugammadex Injection [Bridion]
reversal of neuromuscular blockade with neostigmine \& glycopyrrolate
Drug: Neostigmine+Glycopyrronium
Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe.
Also known as: Sugammadex
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.
Also known as: Neostigmine
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.
Time frame: within 30 minutes after arrival at post-anesthesia care unit (PACU)
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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9, assessed up to 60 minutes
| Milestone | Sugammadex | Neostigmine |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 19 |
| Not completed | 0 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
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.
| units on a scale | Sugammadex | Neostigmine |
|---|---|---|
| Pediatric Anesthesia Emergence Delirium Score | 18 (12.5 to 20) | 18 (9.5 to 20) |
Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7
| seconds | Sugammadex | Neostigmine |
|---|---|---|
| Time Recovery of TOF Ratio to 0.7 | 72.7 ± 37.7 | 167.4 ± 68.6 |
time from administration of reversal agent to time of deep, regular breathing
| seconds | Sugammadex | Neostigmine |
|---|---|---|
| Time to Regular Breathing | 273.8 ± 147.4 | 345.1 ± 214.6 |
time from administration of reversal agent to time of eye opening or child showing purposeful movement
| seconds | Sugammadex | Neostigmine |
|---|---|---|
| Time to Awakening | 275.8 ± 134.6 | 371.2 ± 195.1 |
time from administration of reversal agent to time of tracheal extubation
| seconds | Sugammadex | Neostigmine |
|---|---|---|
| Time to Extubation | 312.1 ± 155.0 | 427.3 ± 184.0 |
Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.8
| seconds | Sugammadex | Neostigmine |
|---|---|---|
| Time Recovery of TOF Ratio to 0.8 | 83.9 ± 42.7 | 213.6 ± 81.8 |
Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9
| seconds | Sugammadex | Neostigmine |
|---|---|---|
| Time Recovery of TOF Ratio to 0.9 | 99.6 ± 38.2 | 253.1 ± 128.5 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sugammadex | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Neostigmine | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
One patient in Neostigmine group was dropped for the violation of protocol.
| Age, Continuous(years) | Sugammadex | Neostigmine | Total |
|---|---|---|---|
| Mean | 5.9 ± 1 | 5.5 ± 1.2 | 5.5 ± 1.1 |
| Sex: Female, Male(Participants) | Sugammadex | Neostigmine | Total |
|---|---|---|---|
| Female | 10 | 9 | 19 |
| Male | 10 | 10 | 20 |
| Race/Ethnicity, Customized(Participants) | Sugammadex | Neostigmine | Total |
|---|---|---|---|
| Asian | 20 | 19 | 39 |
| Region of Enrollment(participants) | Sugammadex | Neostigmine | Total |
|---|---|---|---|
| South Korea | 20 | 19 | 39 |
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Pusan National University Yangsan Hospital