Infantile - Postoperative Residual Curarization - Study

Neuromuscular Blockade Clinical Trial

— I-PORC  

Official title:

Observational Study to Detect Postoperative Residual Curarization in Infantile Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804346
• Other study ID #: 17-449-101
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: July 23, 2017

Study information

• Verified date: January 2019
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 23, 2017
• Est. primary completion date: July 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Neuromuscular Blockade
• Neuromuscular Monitoring
• Postoperative Residual Curarization

Intervention

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

Locations

Country	Name	City	State
Germany	University Hospital Regensburg	Regensburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual paralysis	Rate of residual paralysis after extubation of the infantile patients measured by acceleromyography.	Directly prior to extubation
Secondary	Airway obstruction	Clinical assessment of the upper airway	1, 10, 30, 60 minutes after extubation
Secondary	Oxygen desaturation	Measurement of the oxygen saturation by pulse oxymetry	1, 10, 30, 60 minutes after extubation
Secondary	Bronchospasm, laryngospasm	Clinical assessment the airway	1, 10, 30, 60 minutes after extubation