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Trial record 27 of 188 for:    GLYCOPYRROLATE

Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Pediatric Emergence Delirium in Sevoflurane-rocuronium Anesthesia

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ClinicalTrials.gov Identifier: NCT03229486
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Tae-Kyun Kim, Pusan National University Yangsan Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Emergence Delirium Drug: Sugammadex Injection [Bridion] Drug: Neostigmine+Glycopyrronium Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Prospective, Double-blind, Randomized Study to Investigate the Effect of Sugammadex vs. Neostigmine/Glycopyrrolate on Emergence Delirium During Sevoflurane-rocuronium Anesthesia in Pediatric Patients
Actual Study Start Date : October 17, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Sugammadex Injection [Bridion]
reversal of neuromuscular blockade with sugammadex
Drug: 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.

Active Comparator: Neostigmine+Glycopyrronium
reversal of neuromuscular blockade with neostigmine & glycopyrrolate
Drug: 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.




Primary Outcome Measures :
  1. PAED Score [ Time Frame: within 30 minutes after arrival at post-anesthesia care unit (PACU) ]
    maximum Pediatric Anesthesia Emergence Delirium (PAED) score after arrival in the PACU


Secondary Outcome Measures :
  1. Time recovery of TOF ratio to 0.7, 0.8, and 0.9 [ Time Frame: Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7, 0.8, and 0.9, assessed up to 60 minutes ]
    Time from the start of administration of reversal agents to recovery of the TOF ratio to 0.7, 0.8, and 0.9

  2. Time to regular breathing [ Time Frame: time from administration of reversal agent to time of deep, regular breathing, assessed up to 60 minutes ]
    time from administration of reversal agent to time of deep, regular breathing

  3. Time to awakening [ Time Frame: time from administration of reversal agent to time of eye opening or child showing purposeful movements, assessed up to 60 minutes ]
    time from administration of reversal agent to time of eye opening or child showing purposeful movement

  4. Time to extubation [ Time Frame: time from administration of reversal agent to time of tracheal extubation, assessed up to 60 minutes ]
    time from administration of reversal agent to time of tracheal extubation



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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229486


Contacts
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Contact: Juyeon Park, MD 82553602129 monojp@pusan.ac.kr
Contact: Tae-Kyun Kim, MD, PhD 82553602129 anesktk@pusan.ac.kr

Locations
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Korea, Republic of
Pusan National University Yangsan Hospital Recruiting
Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
Contact: Juyeon Park, MD         
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Principal Investigator: Tae-Kyun Kim, MD, PhD Pusan National University Yangsan Hospital
  Study Documents (Full-Text)

Documents provided by Tae-Kyun Kim, Pusan National University Yangsan Hospital:

Publications of Results:
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Responsible Party: Tae-Kyun Kim, Associate professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT03229486     History of Changes
Other Study ID Numbers: PusanNUYH
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Tae-Kyun Kim, Pusan National University Yangsan Hospital:
emergence delirium
tonsillectomy
Additional relevant MeSH terms:
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Glycopyrrolate
Delirium
Emergence Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Postoperative Complications
Pathologic Processes
Sevoflurane
Rocuronium
Neostigmine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents