NCT02498678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
5 months until next milestone

Results Posted

Study results publicly available

December 11, 2015

Completed
Last Updated

December 11, 2015

Status Verified

November 1, 2015

Enrollment Period

1.5 years

First QC Date

February 11, 2015

Results QC Date

July 17, 2015

Last Update Submit

November 3, 2015

Conditions

Muscle Relaxation

Outcome Measures

Primary Outcomes (2)

  • Train of Four 0,9 (90%)

    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)

    An expected average of 60 minutes

  • T1 Height

    T1 height documentation when train of four reaches 0,9 (90%)

    An expected average of 60 minutes

Secondary Outcomes (3)

  • Time to Obtain T1 Height Stability

    An expected average of 60 minutes

  • Monitor Settings - Electric Current

    An expected average of 60 minutes

  • Monitor Settings - Sensitivity

    An expected average of 60 minutes

Study Arms (2)

control group

NO INTERVENTION

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

EXPERIMENTAL

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

Interventions

TetanusPROCEDURE

tetanic electric stimulation

tetanus group

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Institute

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

  • Carlos RV, de Boer HD, Torres ML, Carmona MJ. The effect of prior tetanic stimulation on train-of-four monitoring in paediatric patients: A randomised open-label controlled trial. Eur J Anaesthesiol. 2017 Mar;34(3):163-168. doi: 10.1097/EJA.0000000000000558.

    PMID: 27828786DERIVED

MeSH Terms

Interventions

Tetanus Toxoid

Intervention Hierarchy (Ancestors)

ToxoidsVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Dr. Ricardo Vieira Carlos
Organization
Instituto da Criança do Hospital das Clínicas da Universidade de São Paulo
ricardovieirac@gmail.com
55-11-99911-6677

Study Officials

  • Marcelo LA Torres, Prof.

    Disciplina de Anestesiologia da FMUSP

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

February 11, 2015

First Posted

July 15, 2015

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 11, 2015

Results First Posted

December 11, 2015

Record last verified: 2015-11

Locations

BR(1)