Infantile - Postoperative Residual Curarization - Study

Completed

• Conditions: Neuromuscular Monitoring; Postoperative Residual Curarization; Neuromuscular Blockade

• Registration Number: NCT03804346
• Lead Sponsor: University of Regensburg

Brief Summary

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

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 Timeline

• Study Start: 2017-05-01
• Primary Completion: 2017-07-23
• Study Completion: 2017-07-23
• Study First Submitted: 2017-12-01
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-13
• Last Update Submitted: 2019-01-13
• Study First Posted: 2019-01-15
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Residual paralysis	Directly prior to extubation	Rate of residual paralysis after extubation of the infantile patients measured by acceleromyography.

Secondary Outcome Measures

Name	Time	Method
Airway obstruction	1, 10, 30, 60 minutes after extubation	Clinical assessment of the upper airway
Oxygen desaturation	1, 10, 30, 60 minutes after extubation	Measurement of the oxygen saturation by pulse oxymetry
Bronchospasm, laryngospasm	1, 10, 30, 60 minutes after extubation	Clinical assessment the airway

Trial Locations

Locations (1)

University Hospital Regensburg; 🇩🇪 Regensburg, Bavaria, Germany