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Effect of Tetanus on Neuromuscular Junction Monitor Performance in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT02498678
Recruitment Status : Completed
First Posted : July 15, 2015
Results First Posted : December 11, 2015
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Ricardo Vieira Carlos, University of Sao Paulo General Hospital

Brief Summary:
The objective of this study is to assess the performance of acceleromyography as a method of evaluation of muscle relaxation after application of tetanus stimulation to obtain stability of responses before administration of neuromuscular blocking agents.

Condition or disease Intervention/treatment Phase
Muscle Relaxation Procedure: Tetanus Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effect of Tetanus on Neuromuscular Junction Monitor Performance in Pediatric Patients Undergoing Abdominal and / or Perineal Surgical Procedures With Using of Rocuronium
Study Start Date : January 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tetanus

Arm Intervention/treatment
No Intervention: control group
After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
Experimental: tetanus group
After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
Procedure: Tetanus
tetanic electric stimulation




Primary Outcome Measures :
  1. Train of Four 0,9 (90%) [ Time Frame: An expected average of 60 minutes ]
    Time to recovery to train of four 0,9 (90%). When the fourth stimulus value (T4) divided by the first stimulus (T1) reaches the ratio of 0.9 (T4 / T1)

  2. T1 Height [ Time Frame: An expected average of 60 minutes ]
    T1 height documentation when train of four reaches 0,9 (90%)


Secondary Outcome Measures :
  1. Time to Obtain T1 Height Stability [ Time Frame: An expected average of 60 minutes ]
    Time, in minutes, for the stabilization T1 height (maximum acceptable variation of up to 5%) before administration of neuromuscular blocking agent. According to the guidelines for good clinical research practice in pharmacodynamics studies of neuromuscular blocking agents, the monitor must present a stable response of T1 height (baseline) for a period of 2-5 min before administration of an neuromuscular blocking agents.

  2. Monitor Settings - Electric Current [ Time Frame: An expected average of 60 minutes ]
    Electric current (milliampere) calculated by the monitor calibration

  3. Monitor Settings - Sensitivity [ Time Frame: An expected average of 60 minutes ]
    Sensitivity calculated by the monitor calibration, It is a numeric value that ranges from 1 to 512, but there is no measurement unit provided. Using the default CAL 2 function, the TOF-Watch® SX monitor automatically determines the sensitivity for a specific patient. The sensitivity can be adjusted between 1 and 512, where 512 represents the most sensitive setting. A sensitivity setting of 157 is the default value. This value represents how the monitor measures motor response of the patient to electrical stimulation of train of four (TOF). If the patient has intense motor response, the monitor reduces its sensitivity. If the patient has poor motor response, the monitor increase your sensitivity.



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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Physical Status 1-2, aged 2 to 11 years, regardless of genders) who will undergo abdominal and / or perineal surgery, with planned surgical time greater than 60 minutes

Exclusion Criteria:

  • Patients with diseases or medications that are known to interfere with neuromuscular transmission, hepatic or renal dysfunction or allergy to medications used in the study will be excluded

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): NCT02498678


Locations
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Brazil
Child Institute
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Study Director: Marcelo LA Torres, Prof. Disciplina de Anestesiologia da FMUSP

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ricardo Vieira Carlos, Staff Physician, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02498678     History of Changes
Other Study ID Numbers: 22225014.7.0000.0068
First Posted: July 15, 2015    Key Record Dates
Results First Posted: December 11, 2015
Last Update Posted: December 11, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Tetanus
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections