Different Reversal Agents in Pediatric Day-case Cancer Surgery
Sugammadex Versus Neostigmine in Pediatric Day-case Cancer Surgery
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockers in pediatric patients undergoing outpatient surgical procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2019
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 18, 2019
CompletedFirst Posted
Study publicly available on registry
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedJune 25, 2019
June 1, 2019
3 months
June 18, 2019
June 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Recovery time
time from neostigmine or sugammadex administration until recovery of the TOF ratio to 0.9%
time from reversal administration until TOF ratio reaches0.9%, ranging from 1 to 2.5 minutes, measured withThe train-of-four (TOF) equipment working with the nerve-muscle acceleromyometry principle (TOF Draeger Medical Systems, Inc.16 Electronic Avenue,
Secondary Outcomes (1)
extubation time
time from muscle relaxant administration until extubation,extubation will be performed based on clinical criteria extubation timeis estimated to range from 50 to 55 minutes
Study Arms (2)
Group S
EXPERIMENTALSugammadex for reversal of steroidal neuromuscular blockers, intravenous injection ,2mg/kg
Group N
ACTIVE COMPARATORReversal of neuromuscular blockers, iv injection, 0.05 mg/kg
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥2 years and \< 18 years.
- American society of anesthesiologists (ASA) status 1-3.
- patients undergoing outpatient procedures
You may not qualify if:
- Known drug hypersensitivity.-
- History of renal or hepatic failure.
- Diseases of the neuromuscular junction.
- history of malignant hyperthermia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Ammar AS, Mahmoud KM, Kasemy ZA. A comparison of sugammadex and neostigmine for reversal of rocuronium-induced neuromuscular blockade in children. Acta Anaesthesiol Scand. 2017 Apr;61(4):374-380. doi: 10.1111/aas.12868. Epub 2017 Feb 10.
PMID: 28185260BACKGROUNDMeretoja OA. Neuromuscular block and current treatment strategies for its reversal in children. Paediatr Anaesth. 2010 Jul;20(7):591-604. doi: 10.1111/j.1460-9592.2010.03335.x.
PMID: 20642658BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohamed MO Hegazy, MD
Cairo University
- STUDY DIRECTOR
Mohamed Ad Elramly, MD
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior registra
Study Record Dates
First Submitted
June 18, 2019
First Posted
June 25, 2019
Study Start
June 1, 2019
Primary Completion
September 1, 2019
Study Completion
October 1, 2019
Last Updated
June 25, 2019
Record last verified: 2019-06