Infantile - Postoperative Residual Curarization - Study (I-PORC)

January 13, 2019 updated by: Christoph Unterbuchner, University of Regensburg

Observational Study to Detect Postoperative Residual Curarization in Infantile Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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,

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • University Hospital Regensburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children/youths between 1 Month to 18 years who are undergoing general anaesthesia with muscle relaxation due to surgical or diagnostical procedures.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual paralysis
Time Frame: Directly prior to extubation
Rate of residual paralysis after extubation of the infantile patients measured by acceleromyography.
Directly prior to extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Airway obstruction
Time Frame: 1, 10, 30, 60 minutes after extubation
Clinical assessment of the upper airway
1, 10, 30, 60 minutes after extubation
Oxygen desaturation
Time Frame: 1, 10, 30, 60 minutes after extubation
Measurement of the oxygen saturation by pulse oxymetry
1, 10, 30, 60 minutes after extubation
Bronchospasm, laryngospasm
Time Frame: 1, 10, 30, 60 minutes after extubation
Clinical assessment the airway
1, 10, 30, 60 minutes after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regensburg

Investigators

  • Principal Investigator: Christoph Unterbuchner, MD, University medical center Regensburg, Department of anaesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

July 23, 2017

Study Completion (Actual)

July 23, 2017

Study Registration Dates

First Submitted

December 1, 2017

First Submitted That Met QC Criteria

January 13, 2019

First Posted (Actual)

January 15, 2019

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 13, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-449-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Postoperative Residual Curarization

Clinical Trials on Acceleromyography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe