Different Reversal Agents in Pediatric Day-case Cancer Surgery
Primary Purpose
Post-operative Residual Curarization
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sugammadex Injection [Bridion]
Neostigmine
Sponsored by
About this trial
This is an interventional prevention trial for Post-operative Residual Curarization
Eligibility Criteria
Inclusion Criteria:
- Age ≥2 years and < 18 years.
- American society of anesthesiologists (ASA) status 1-3.
- patients undergoing outpatient procedures
Exclusion Criteria:
- Known drug hypersensitivity.-
- History of renal or hepatic failure.
- Diseases of the neuromuscular junction.
- history of malignant hyperthermia.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group S
Group N
Arm Description
Sugammadex for reversal of steroidal neuromuscular blockers, intravenous injection ,2mg/kg
Reversal of neuromuscular blockers, iv injection, 0.05 mg/kg
Outcomes
Primary Outcome Measures
Recovery time
time from neostigmine or sugammadex administration until recovery of the TOF ratio to 0.9%
Secondary Outcome Measures
extubation time
time from neuromuscular blocker administration to extubation
Full Information
NCT ID
NCT03996655
First Posted
June 18, 2019
Last Updated
June 21, 2019
Sponsor
National Cancer Institute, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT03996655
Brief Title
Different Reversal Agents in Pediatric Day-case Cancer Surgery
Official Title
Sugammadex Versus Neostigmine in Pediatric Day-case Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
Detailed Description
Postoperative residual curarization (PORC)" a residual duration of action of muscle relaxants beyond the end of the operation" in postoperative patients is a succession of the presence of blocked nicotinic receptors. Even in observationally asymptomatic patients, 60-70% of these receptors can be still blocked. PORC can cause delayed recovery, hypoxia, metabolic derangement and rarely death. Cholinesterase inhibitors are traditionally used for reversal of neuromuscular blockade (NMB). Among these agents neostigmine is the most potent and selective one. Cholinesterase inhibitors have multisystemic side effects. Since these agents are not selective to nicotinic receptors and also stimulate the muscarinic system, there can be quite a few serious adverse effects as follows: Bradycardia, QT lengthening, bronchoconstriction, hypersalivation and increased motility. To avoid these effects, concomitant anticholinergic agents, such as atropine or glycopyrolate, are administered to the patient. The incidence of PORC is still high with the prevalence of a train-of-four (TOF) ratio of less than 0.9 found in the postoperative recovery unit. Recent studies have been able to link even low levels of residual paralysis (TOF ratio <0.9) with significant impairment of pharyngeal muscle function, hypoxic ventilatory drive and decreased respiratory function in the immediate postoperative period.
Despite the knowledge of such side effects, and despite the introduction of various new neuromuscular blocking agents (NMBA) such as rocuronium or mivacurium over the last 15 years, no significant reduction in the incidence of residual neuromuscular blockade has so far been observable.
Today, sugammadex is an alternative to the decurarization procedure, which was traditionally executed with cholinesterase inhibitors. Sugammadex a γ-cyclodextrin with a high affinity to rocuronium and other aminosteroidal NMBA that allows the rapid and complete reversal of especially rocuronium-induced neuromuscular blockade, has raised hopes to overcome the problem of residual neuromuscular blockade. Sugammadex is proved to be a safe and superior agent in NMB reversal compared to neostigmine in adults.
PORC and the muscarinic side effects are not anticipated when using sugammadex,.
Also, due to its pharmacodynamic profile, sugammadex, in combination with rocuronium, have the potential to displace succinylcholine as the "gold standard" muscle relaxant for rapid sequence induction.
The rudimentary neuromuscular junction, the variability of fibrin fibers, the differences in drug distribution and body volume in children change their neuromuscular conduction. These factors can cause prolonged recovery and increased risk of PORC. However, there is few studies in the literature concerning sugammadex administration in pediatric patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Residual Curarization
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group S
Arm Type
Experimental
Arm Description
Sugammadex for reversal of steroidal neuromuscular blockers, intravenous injection ,2mg/kg
Arm Title
Group N
Arm Type
Active Comparator
Arm Description
Reversal of neuromuscular blockers, iv injection, 0.05 mg/kg
Intervention Type
Drug
Intervention Name(s)
Sugammadex Injection [Bridion]
Intervention Description
Reversal of neuromuscular blockers
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Intervention Description
Reversal of neuromuscular blockers
Primary Outcome Measure Information:
Title
Recovery time
Description
time from neostigmine or sugammadex administration until recovery of the TOF ratio to 0.9%
Time Frame
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 Outcome Measure Information:
Title
extubation time
Description
time from neuromuscular blocker administration to extubation
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥2 years and < 18 years.
American society of anesthesiologists (ASA) status 1-3.
patients undergoing outpatient procedures
Exclusion Criteria:
Known drug hypersensitivity.-
History of renal or hepatic failure.
Diseases of the neuromuscular junction.
history of malignant hyperthermia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amani Ga Mohamed, MSc
Phone
(202)01119611061
Email
amanigabr@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed MO Hegazy, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed Ad Elramly, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
28185260
Citation
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.
Results Reference
background
PubMed Identifier
20642658
Citation
Meretoja 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.
Results Reference
background
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Different Reversal Agents in Pediatric Day-case Cancer Surgery
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