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Infantile - Postoperative Residual Curarization - Study

Observational Study to Detect Postoperative Residual Curarization in Infantile Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03804346
Acronym
I-PORC
Enrollment
100
Registered
2019-01-15
Start date
2017-05-01
Completion date
2017-07-23
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular Blockade, Neuromuscular Monitoring, Postoperative Residual Curarization

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,

Interventions

DIAGNOSTIC_TESTAcceleromyography

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

Sponsors

University of Regensburg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Residual paralysisDirectly prior to extubationRate of residual paralysis after extubation of the infantile patients measured by acceleromyography.

Secondary

MeasureTime frameDescription
Airway obstruction1, 10, 30, 60 minutes after extubationClinical assessment of the upper airway
Oxygen desaturation1, 10, 30, 60 minutes after extubationMeasurement of the oxygen saturation by pulse oxymetry
Bronchospasm, laryngospasm1, 10, 30, 60 minutes after extubationClinical assessment the airway

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026