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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
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-operative Residual Curarization

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 18, 2019
    Last Updated
    June 21, 2019
    Sponsor
    National Cancer Institute, Egypt
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    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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