Emergence DeliriumPhase 4NCT03229486
Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia
A Phase 4 study testing Sugammadex Injection [Bridion] and Neostigmine+Glycopyrronium in people with Emergence Delirium, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Sugammadex Injection [Bridion] and Neostigmine+Glycopyrronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2017to 30 Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Emergence Delirium
- Being tested
- Sugammadex Injection [Bridion], Neostigmine+Glycopyrronium
- Keywords
- emergence delirium, tonsillectomy
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugammadex Injection [Bridion]Drug
Also called Sugammadex
Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe.
Neostigmine+GlycopyrroniumDrug
Also called Neostigmine
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.
| Study group | Role | What they receive |
|---|---|---|
| Sugammadex Injection [Bridion] | Experimental | reversal of neuromuscular blockade with sugammadex Receives: Drug: Sugammadex Injection [Bridion] |
| Neostigmine+Glycopyrronium | Active comparator | reversal of neuromuscular blockade with neostigmine \& glycopyrrolate Receives: Drug: Neostigmine+Glycopyrronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 minutes after arrival at post-anesthesia care unit (PACU)
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9, assessed up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Mar 2017
- Primary completion30 Jul 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Kyun Kim, Pusan National University Yangsan Hospital
- Investigators
- Tae-Kyun Kim, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229486
- Sponsor's protocol ID
- PusanNUYH
- Status last verified
- Mar 2020
- First submitted
- 29 Jun 2017
- Last updated
- 17 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19194156Locatelli 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.
PubMed 23043512Pieters 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.
PubMed 20735801
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03229486
- Acronym / sponsor ID
- PusanNUYH
- Conditions
- Emergence Delirium
- Keywords
- emergence delirium, tonsillectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 25 Jul 2017 (actual)
- Results
- Posted 17 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugammadex Injection [Bridion] | Experimental | Drug: Sugammadex Injection [Bridion]reversal of neuromuscular blockade with sugammadex |
| Neostigmine+Glycopyrronium | Active comparator | Drug: Neostigmine+Glycopyrroniumreversal of neuromuscular blockade with neostigmine \& glycopyrrolate |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sugammadex Injection [Bridion]Also: SugammadexReturn to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe. | Drug | Sugammadex Injection [Bridion] |
| Neostigmine+GlycopyrroniumAlso: NeostigmineReturn 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. | Drug | Neostigmine+Glycopyrronium |
Primary outcome
Pediatric Anesthesia Emergence Delirium Score
Time frame: 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.
6 secondary outcomes
Time Recovery of 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 frame: time from administration of reversal agent to time of deep, regular breathing, assessed up to 60 minutes
Time to Awakening
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 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 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 frame: Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9, assessed up to 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19194156Plaud 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.
- Background: PubMed 23043512Locatelli 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.
- Background: PubMed 20735801Pieters 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tae-Kyun Kim, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sugammadex Injection [Bridion] and Neostigmine+Glycopyrronium in people with Emergence Delirium, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Anesthesia Emergence Delirium Score (time frame: within 30 minutes after arrival at post-anesthesia care unit (PACU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03229486, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.