Phase 4
N=40
Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia
Emergence Delirium
Bottom Line
View on ClinicalTrials.gov: NCT03229486 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Pediatric Anesthesia Emergence Delirium Score — 18; 18 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex Injection [Bridion] (Drug); Neostigmine+Glycopyrronium (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Pusan National University Yangsan Hospital
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pediatric Anesthesia Emergence Delirium Score |
18; 18 | — |
| SECONDARY Time Recovery of TOF Ratio to 0.7 |
72.7; 167.4 | — |
| SECONDARY Time to Regular Breathing |
273.8; 345.1 | — |
| SECONDARY Time to Awakening |
275.8; 371.2 | — |
| SECONDARY Time to Extubation |
312.1; 427.3 | — |
| SECONDARY Time Recovery of TOF Ratio to 0.8 |
83.9; 213.6 | — |
| SECONDARY Time Recovery of TOF Ratio to 0.9 |
99.6; 253.1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03229486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.