Trial Outcomes & Findings for Effect of Tetanus on Neuromuscular Junction Monitor Performance in Pediatric Patients (NCT NCT02498678)
NCT ID: NCT02498678
Last Updated: 2015-12-11
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
An expected average of 60 minutes
Results posted on
2015-12-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
Tetanus: tetanic electric stimulation
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
Tetanus: tetanic electric stimulation
|
|---|---|---|
|
Overall Study
interference from the surgical team
|
0
|
2
|
Baseline Characteristics
Effect of Tetanus on Neuromuscular Junction Monitor Performance in Pediatric Patients
Baseline characteristics by cohort
| Measure |
Control Group
n=25 Participants
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.
|
Tetanus Group
n=23 Participants
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
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.8 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
5.6 years
STANDARD_DEVIATION 2.35 • n=7 Participants
|
6.2 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
25 participants
n=5 Participants
|
23 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Body mass index
|
17.2 kilogram per square meter
STANDARD_DEVIATION 7.6 • n=5 Participants
|
15.7 kilogram per square meter
STANDARD_DEVIATION 1.3 • n=7 Participants
|
16.5 kilogram per square meter
STANDARD_DEVIATION 5.56 • n=5 Participants
|
|
Growth chart percentiles
|
38.5 percentile
STANDARD_DEVIATION 27 • n=5 Participants
|
44.6 percentile
STANDARD_DEVIATION 22.2 • n=7 Participants
|
41.3 percentile
STANDARD_DEVIATION 24.9 • n=5 Participants
|
|
ASA physical status
1
|
15 participants
n=5 Participants
|
18 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
ASA physical status
2
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: An expected average of 60 minutesTime 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)
Outcome measures
| Measure |
Control Group
n=25 Participants
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.
|
Tetanus Group
n=23 Participants
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
|
|---|---|---|
|
Train of Four 0,9 (90%)
|
49.9 minutes
Standard Deviation 12.2
|
41.7 minutes
Standard Deviation 13.1
|
PRIMARY outcome
Timeframe: An expected average of 60 minutesT1 height documentation when train of four reaches 0,9 (90%)
Outcome measures
| Measure |
Control Group
n=25 Participants
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.
|
Tetanus Group
n=23 Participants
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
|
|---|---|---|
|
T1 Height
|
95.3 percentage of T1 height
Standard Deviation 15.8
|
69.3 percentage of T1 height
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: An expected average of 60 minutesTime, 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.
Outcome measures
| Measure |
Control Group
n=25 Participants
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.
|
Tetanus Group
n=23 Participants
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
|
|---|---|---|
|
Time to Obtain T1 Height Stability
|
195 seconds
Standard Deviation 203
|
116 seconds
Standard Deviation 81.6
|
SECONDARY outcome
Timeframe: An expected average of 60 minutesElectric current (milliampere) calculated by the monitor calibration
Outcome measures
| Measure |
Control Group
n=25 Participants
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.
|
Tetanus Group
n=23 Participants
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
|
|---|---|---|
|
Monitor Settings - Electric Current
|
48.2 milliampere
Standard Deviation 12.1
|
47.2 milliampere
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: An expected average of 60 minutesSensitivity 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.
Outcome measures
| Measure |
Control Group
n=25 Participants
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.
|
Tetanus Group
n=23 Participants
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
|
|---|---|---|
|
Monitor Settings - Sensitivity
|
128 units on a scale from 1 to 512
Standard Deviation 41.1
|
103.8 units on a scale from 1 to 512
Standard Deviation 49.8
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tetanus Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ricardo Vieira Carlos
Instituto da Criança do Hospital das Clínicas da Universidade de São Paulo
Phone: 55-11-99911-6677
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place