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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03775603
Recruitment Status : Recruiting
First Posted : December 14, 2018
Last Update Posted : March 7, 2019
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

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 identifier (NCT number): NCT03775603

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Contact: Hee-Soo Kim +821052878006

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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   
Contact: Hee-Soo Kim, MD, MS    +821052878006   
Sponsors and Collaborators
Seoul National University Hospital
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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 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