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Clinical Trials/NCT03804346
NCT03804346
Completed
Not Applicable

Observational Study to Detect Postoperative Residual Curarization in Infantile Patients

University of Regensburg1 site in 1 country100 target enrollmentMay 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Residual Curarization
Sponsor
University of Regensburg
Enrollment
100
Locations
1
Primary Endpoint
Residual paralysis
Status
Completed
Last Updated
7 years ago

Overview

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,

Registry
clinicaltrials.gov
Start Date
May 1, 2017
End Date
July 23, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christoph Unterbuchner

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

University of Regensburg

Eligibility Criteria

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

Outcomes

Primary Outcomes

Residual paralysis

Time Frame: Directly prior to extubation

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

Secondary Outcomes

  • Airway obstruction(1, 10, 30, 60 minutes after extubation)
  • Oxygen desaturation(1, 10, 30, 60 minutes after extubation)
  • Bronchospasm, laryngospasm(1, 10, 30, 60 minutes after extubation)

Study Sites (1)

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