Infantile - Postoperative Residual Curarization - Study

NCT ID: NCT03804346

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2017-07-23

Brief Summary

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The primary object of this study is, to investigate the current procedure of neuromuscular monitoring at a tertiary academic university medical center.

Detailed Description

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Residual neuromuscular block is known to be a significant but frequently overlooked complication after the use of neuromuscular blocking agents. Aim of this prospective, observational study is to detect the incidence and severity of residual paralysis at a tertiary academic german university medical center.

Methods:

All infantile patients recieving neuromuscular blocking agents are included over a 12 week observational period. At the end of the operation procedure, directly prior to tracheal extubation a train-of-four ratio was assessed quantitatively by an independet observer using the TOF Watch SX monitor. Data related to patient postoperative outcome were collected in the operating theatre, during the way to the postoperative care unit (PACU) and during the stay in the PACU:

* incidence of residual paralysis
* incidence of aspiration, bronchospasm, laryngospasm, oxygen desaturation, airway obstruction,

Conditions

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Postoperative Residual Curarization Neuromuscular Blockade Neuromuscular Monitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Acceleromyography

At the End of Surgery, shortly before Extubation, the TOF-Ratio is measured by an independent investigator using Acceleromyography.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* General aneasthesia with muscle relaxation
* Children between 1 Month to 18 Years
* Endotracheal Intubation due to surgical or diagnostical procedures

Exclusion Criteria

* older than 18 years
* local aneasthesia
* regional aneasthesia
* larynx mask
* patient comes from ICU
* children who are not planned to be extubated
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Regensburg

OTHER

Sponsor Role lead

Responsible Party

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Christoph Unterbuchner

Principal Investigator, Dr. med. Christoph Unterbuchner, Staff Anaesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christoph Unterbuchner, MD

Role: PRINCIPAL_INVESTIGATOR

University medical center Regensburg, Department of anaesthesiology

Locations

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University Hospital Regensburg

Regensburg, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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17-449-101

Identifier Type: -

Identifier Source: org_study_id

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