NCT02939911

Brief Summary

Residual neuromuscular blockade (RNB) is frequent and it is associated with postoperative morbidity and mortality. The incidence of the RNB in pediatric anesthesia is currently not known. The aim of this prospective observational cohort study is to evaluate the early RNB just before extubation and late RNB at the time of arrival to postanesthetic care unit (PACU).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
291

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 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

First Submitted

Initial submission to the registry

October 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

November 19, 2018

Status Verified

November 1, 2018

Enrollment Period

11 months

First QC Date

October 18, 2016

Last Update Submit

November 16, 2018

Conditions

Residual Neuromuscular Blockade

Keywords

Residual neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

  • Early residual neuromuscular blockade

    Just prior extubation the residual neuromuscular blockade will be measured by accelerometry

    before extubation

Secondary Outcomes (1)

  • Late neuromuscular blockade

    at arrival to PACU

Study Arms (1)

Paediatric patients after NMBA administration

Paediatric patients undergoing surgery with neuromuscular blockade

Device: Residual neuromuscular blockade measurement

Interventions

Residual neuromuscular blockade measurementDEVICE

Just prior extubation in OR and at the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry

Also known as: accelerometry
Paediatric patients after NMBA administration

Eligibility Criteria

Age29 Weeks - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Paediatric patients undergoing surgery with neuromuscular blocking agents were administered

You may qualify if:

  • Paediatric patients undergoing surgery with neuromuscular blocking agents were administered with the age limits

You may not qualify if:

  • weight under 3000 grams
  • neuromuscular disease
  • haemodynamic impairment (vasopressor need)
  • planned postoperative mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brno University Hospital

Brno, 62500, Czechia

Location

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Accelerometry

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doc.MD.Ph.D

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 20, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

November 19, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

Locations

CZ(1)