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Comparison of TOFscan and TOF-Watch SX in Pediatric Neuromuscular Function Recovery

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ClinicalTrials.gov Identifier: NCT03775603
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hee-Soo Kim, Seoul National University Hospital

Brief Summary:
Comparison of TOFscan and TOF-Watch SX for monitoring of neuromuscular blockade function in children

Condition or disease Intervention/treatment
Neuromuscular Blockade Device: TOFscan

Detailed Description:
TOF ratio of TOFscan when TOF-Watch SX shows TOF ratio 0.7 with rocuronium in children during general anesthesia

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Study Type : Observational
Estimated Enrollment : 37 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Comparison of TOFscan and TOF-Watch SX in Children
Actual Study Start Date : March 2, 2019
Estimated Primary Completion Date : January 9, 2020
Estimated Study Completion Date : May 30, 2020

Intervention Details:
  • Device: TOFscan
    comparison of TOFscan over TOF-Watch SX


Primary Outcome Measures :
  1. TOF ratio of TOFscan [ Time Frame: intraoperative during anesthesia ]
    value of TOF ratio of TOFscan at TOF ratio 0.7 of TOF-Watch SX during neuromuscular function recovery period



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
general anesthesia with neuromuscular blockade in children
Criteria

Inclusion Criteria:

  • patients need neuromuscular blockade

Exclusion Criteria:

  • contraindication of rocuronium

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): NCT03775603


Contacts
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Contact: Hee-Soo Kim +821052878006 dami0605@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Hee-Soo Kim, MD, Ph.D    +82-2-2072-3661    dami0605@snu.ac.kr   
Contact: Hee-Soo Kim, MD, MS    +821052878006    dami0605@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Hee-Soo Kim Seoul National University

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Responsible Party: Hee-Soo Kim, principal investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03775603     History of Changes
Other Study ID Numbers: 1811-137-989
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No