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Completed

NCT Number: NCT03804346

Infantile - Postoperative Residual Curarization - Study

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

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Key information

Conditions

Postoperative Residual Curarization Delayed Emergence from Anesthesia Neuromuscular Blockade Neuromuscular Monitoring Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Regensburg

Regensburg, Bavaria, 93053, Germany

About this study

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,

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acceleromyography

Diagnostic Test

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

Primary outcomes

  1. Residual paralysis

    Time frame: Directly prior to extubation

    Rate of residual paralysis after extubation of the infantile patients measured by acceleromyography.

Secondary outcomes

  1. Airway obstruction

    Time frame: 1, 10, 30, 60 minutes after extubation

    Clinical assessment of the upper airway

  2. Oxygen desaturation

    Time frame: 1, 10, 30, 60 minutes after extubation

    Measurement of the oxygen saturation by pulse oxymetry

  3. Bronchospasm, laryngospasm

    Time frame: 1, 10, 30, 60 minutes after extubation

    Clinical assessment the airway

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

Observational Study to Detect Postoperative Residual Curarization in Infantile Patients

Acronym: I-PORC

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 15, 2019
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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