NCT03804346

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2017

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

December 1, 2017

Last Update Submit

January 13, 2019

Conditions

Postoperative Residual CurarizationNeuromuscular BlockadeNeuromuscular Monitoring

Outcome Measures

Primary Outcomes (1)

  • Residual paralysis

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

    Directly prior to extubation

Secondary Outcomes (3)

  • 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

Interventions

AcceleromyographyDIAGNOSTIC_TEST

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

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All children/youths between 1 Month to 18 years who are undergoing general anaesthesia with muscle relaxation due to surgical or diagnostical procedures.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Regensburg

Regensburg, Bavaria, 93053, Germany

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christoph Unterbuchner, MD

    University medical center Regensburg, Department of anaesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Dr. med. Christoph Unterbuchner, Staff Anaesthesiologist

Study Record Dates

First Submitted

December 1, 2017

First Posted

January 15, 2019

Study Start

May 1, 2017

Primary Completion

July 23, 2017

Study Completion

July 23, 2017

Last Updated

January 15, 2019

Record last verified: 2019-01

Locations

DE(1)