Emergence Delirium
Conditions
Keywords
emergence delirium, tonsillectomy
Brief summary
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
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.
Interventions
Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe.
DRUGNeostigmine+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.
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Anesthesia Emergence Delirium Score | within 30 minutes after arrival at post-anesthesia care unit (PACU) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Regular Breathing | time from administration of reversal agent to time of deep, regular breathing, assessed up to 60 minutes | time from administration of reversal agent to time of deep, regular breathing |
| Time to Awakening | time from administration of reversal agent to time of eye opening or child showing purposeful movements, assessed up to 60 minutes | time from administration of reversal agent to time of eye opening or child showing purposeful movement |
| 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, assessed up to 60 minutes | Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7 |
| 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, assessed up to 60 minutes | Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.8 |
| 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, assessed up to 60 minutes | Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9 |
| Time to Extubation | time from administration of reversal agent to time of tracheal extubation, assessed up to 60 minutes | time from administration of reversal agent to time of tracheal extubation |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 19 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Neostigmine | Total | Sugammadex |
|---|---|---|---|
| Age, Continuous | 5.5 years STANDARD_DEVIATION 1.2 | 5.5 years STANDARD_DEVIATION 1.1 | 5.9 years STANDARD_DEVIATION 1 |
| Race/Ethnicity, Customized Asian | 19 Participants | 39 Participants | 20 Participants |
| Region of Enrollment South Korea | 19 participants | 39 participants | 20 participants |
| Sex: Female, Male Female | 9 Participants | 19 Participants | 10 Participants |
| Sex: Female, Male Male | 10 Participants | 20 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: within 30 minutes after arrival at post-anesthesia care unit (PACU)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sugammadex | Pediatric Anesthesia Emergence Delirium Score | 18 units on a scale |
| Neostigmine | Pediatric Anesthesia Emergence Delirium Score | 18 units on a scale |
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
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Time Recovery of TOF Ratio to 0.7 | 72.7 seconds | Standard Deviation 37.7 |
| Neostigmine | Time Recovery of TOF Ratio to 0.7 | 167.4 seconds | Standard Deviation 68.6 |
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
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Time Recovery of TOF Ratio to 0.8 | 83.9 seconds | Standard Deviation 42.7 |
| Neostigmine | Time Recovery of TOF Ratio to 0.8 | 213.6 seconds | Standard Deviation 81.8 |
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
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Time Recovery of TOF Ratio to 0.9 | 99.6 seconds | Standard Deviation 38.2 |
| Neostigmine | Time Recovery of TOF Ratio to 0.9 | 253.1 seconds | Standard Deviation 128.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Time to Awakening | 275.8 seconds | Standard Deviation 134.6 |
| Neostigmine | Time to Awakening | 371.2 seconds | Standard Deviation 195.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Time to Extubation | 312.1 seconds | Standard Deviation 155 |
| Neostigmine | Time to Extubation | 427.3 seconds | Standard Deviation 184 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sugammadex | Time to Regular Breathing | 273.8 seconds | Standard Deviation 147.4 |
| Neostigmine | Time to Regular Breathing | 345.1 seconds | Standard Deviation 214.6 |