Trial Outcomes & Findings for Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia (NCT NCT03229486)
NCT ID: NCT03229486
Last Updated: 2020-03-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
within 30 minutes after arrival at post-anesthesia care unit (PACU)
Results posted on
2020-03-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia
Baseline characteristics by cohort
| Measure |
Sugammadex
n=20 Participants
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.
|
Neostigmine
n=19 Participants
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.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.9 years
STANDARD_DEVIATION 1 • n=99 Participants
|
5.5 years
STANDARD_DEVIATION 1.2 • n=107 Participants
|
5.5 years
STANDARD_DEVIATION 1.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Region of Enrollment
South Korea
|
20 participants
n=99 Participants
|
19 participants
n=107 Participants
|
39 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Sugammadex
n=20 Participants
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.
|
Neostigmine
n=19 Participants
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.
|
|---|---|---|
|
Pediatric Anesthesia Emergence Delirium Score
|
18 units on a scale
Interval 12.5 to 20.0
|
18 units on a scale
Interval 9.5 to 20.0
|
SECONDARY outcome
Timeframe: Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7, assessed up to 60 minutesTime from the start of administration of reversal agents to recovery of the TOF ratio to 0.7
Outcome measures
| Measure |
Sugammadex
n=20 Participants
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.
|
Neostigmine
n=19 Participants
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.
|
|---|---|---|
|
Time Recovery of TOF Ratio to 0.7
|
72.7 seconds
Standard Deviation 37.7
|
167.4 seconds
Standard Deviation 68.6
|
SECONDARY outcome
Timeframe: time from administration of reversal agent to time of deep, regular breathing, assessed up to 60 minutestime from administration of reversal agent to time of deep, regular breathing
Outcome measures
| Measure |
Sugammadex
n=20 Participants
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.
|
Neostigmine
n=19 Participants
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.
|
|---|---|---|
|
Time to Regular Breathing
|
273.8 seconds
Standard Deviation 147.4
|
345.1 seconds
Standard Deviation 214.6
|
SECONDARY outcome
Timeframe: time from administration of reversal agent to time of eye opening or child showing purposeful movements, assessed up to 60 minutestime from administration of reversal agent to time of eye opening or child showing purposeful movement
Outcome measures
| Measure |
Sugammadex
n=20 Participants
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.
|
Neostigmine
n=19 Participants
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.
|
|---|---|---|
|
Time to Awakening
|
275.8 seconds
Standard Deviation 134.6
|
371.2 seconds
Standard Deviation 195.1
|
SECONDARY outcome
Timeframe: time from administration of reversal agent to time of tracheal extubation, assessed up to 60 minutestime from administration of reversal agent to time of tracheal extubation
Outcome measures
| Measure |
Sugammadex
n=20 Participants
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.
|
Neostigmine
n=19 Participants
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.
|
|---|---|---|
|
Time to Extubation
|
312.1 seconds
Standard Deviation 155.0
|
427.3 seconds
Standard Deviation 184.0
|
SECONDARY outcome
Timeframe: Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.8, assessed up to 60 minutesTime from the start of administration of reversal agents to recovery of the TOF ratio to 0.8
Outcome measures
| Measure |
Sugammadex
n=20 Participants
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.
|
Neostigmine
n=19 Participants
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.
|
|---|---|---|
|
Time Recovery of TOF Ratio to 0.8
|
83.9 seconds
Standard Deviation 42.7
|
213.6 seconds
Standard Deviation 81.8
|
SECONDARY outcome
Timeframe: Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.9, assessed up to 60 minutesTime from the start of administration of reversal agents to recovery of the TOF ratio to 0.9
Outcome measures
| Measure |
Sugammadex
n=20 Participants
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.
|
Neostigmine
n=19 Participants
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.
|
|---|---|---|
|
Time Recovery of TOF Ratio to 0.9
|
99.6 seconds
Standard Deviation 38.2
|
253.1 seconds
Standard Deviation 128.5
|
Adverse Events
Sugammadex
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Neostigmine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place