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Trial record 1 of 1 for:    "Tetanus" | "Sevoflurane"
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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Muscle Relaxation
Intervention Procedure: Tetanus
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Tetanus Group
Hide Arm/Group Description 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.

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.

Tetanus: tetanic electric stimulation

Period Title: Overall Study
Started 25 25
Completed 25 23
Not Completed 0 2
Reason Not Completed
interference from the surgical team             0             2
Arm/Group Title Control Group Tetanus Group Total
Hide Arm/Group Description 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.

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.

Tetanus: tetanic electric stimulation

Total of all reporting groups
Overall Number of Baseline Participants 25 23 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 23 participants 48 participants
6.8  (2.7) 5.6  (2.35) 6.2  (2.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
Female
9
  36.0%
3
  13.0%
12
  25.0%
Male
16
  64.0%
20
  87.0%
36
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 25 participants 23 participants 48 participants
25 23 48
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 25 participants 23 participants 48 participants
17.2  (7.6) 15.7  (1.3) 16.5  (5.56)
Growth chart percentiles  
Mean (Standard Deviation)
Unit of measure:  Percentile
Number Analyzed 25 participants 23 participants 48 participants
38.5  (27) 44.6  (22.2) 41.3  (24.9)
ASA physical status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants 23 participants 48 participants
1 15 18 33
2 10 5 15
[1]
Measure Description:
  1. - A normal healthy patient
  2. - A patient with mild systemic disease
1.Primary Outcome
Title Train of Four 0,9 (90%)
Hide Description 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)
Time Frame An expected average of 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Tetanus Group
Hide Arm/Group Description:
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.

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.

Tetanus: tetanic electric stimulation

Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: minutes
49.9  (12.2) 41.7  (13.1)
2.Primary Outcome
Title T1 Height
Hide Description T1 height documentation when train of four reaches 0,9 (90%)
Time Frame An expected average of 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Tetanus Group
Hide Arm/Group Description:
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.

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.

Tetanus: tetanic electric stimulation

Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: percentage of T1 height
95.3  (15.8) 69.3  (8.7)
3.Secondary Outcome
Title Time to Obtain T1 Height Stability
Hide Description 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.
Time Frame An expected average of 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Tetanus Group
Hide Arm/Group Description:
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.

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.

Tetanus: tetanic electric stimulation

Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: seconds
195  (203) 116  (81.6)
4.Secondary Outcome
Title Monitor Settings - Electric Current
Hide Description Electric current (milliampere) calculated by the monitor calibration
Time Frame An expected average of 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Tetanus Group
Hide Arm/Group Description:
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.

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.

Tetanus: tetanic electric stimulation

Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: milliampere
48.2  (12.1) 47.2  (13.5)
5.Secondary Outcome
Title Monitor Settings - Sensitivity
Hide Description 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.
Time Frame An expected average of 60 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Tetanus Group
Hide Arm/Group Description:
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.

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.

Tetanus: tetanic electric stimulation

Overall Number of Participants Analyzed 25 23
Mean (Standard Deviation)
Unit of Measure: units on a scale from 1 to 512
128  (41.1) 103.8  (49.8)
Time Frame Reported adverse events include events starting with beginning of neuromuscular blockade monitoring and up to 24 hours after end of case
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Tetanus Group
Hide Arm/Group Description 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.

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.

Tetanus: tetanic electric stimulation

All-Cause Mortality
Control Group Tetanus Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group Tetanus Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group Tetanus Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ricardo Vieira Carlos
Organization: Instituto da Criança do Hospital das Clínicas da Universidade de São Paulo
Phone: 55-11-99911-6677
EMail: ricardovieirac@gmail.com
Layout table for additonal information
Responsible Party: Ricardo Vieira Carlos, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02498678     History of Changes
Other Study ID Numbers: 22225014.7.0000.0068
First Submitted: February 11, 2015
First Posted: July 15, 2015
Results First Submitted: July 17, 2015
Results First Posted: December 11, 2015
Last Update Posted: December 11, 2015