NCT01786863

Brief Summary

This study is designed to investigate the frequency of Residual Neuromuscular Blockade (RNMB) in the pediatric population.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.8 years

First QC Date

February 6, 2013

Last Update Submit

November 30, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • train-of-four (TOF) ratio

    TOF ratio shows the residual of neuromuscular agents.

    1 day

Study Arms (1)

Neuromuscular blockade

Procedure: Neuromuscular blockade

Interventions

Neuromuscular blockade

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgery that requires them to be paralyzed

You may qualify if:

  • Age less than 18 years.
  • Surgery requiring the administration of neuromuscular blocking, agents with planned extubation in the postoperative care unit (PACU).

You may not qualify if:

  • Neuromuscular diseases which may prolong the duration of NMBA's or exaggerate the effects of residual blockade.
  • The need for postoperative mechanical ventilation.
  • Direct admission to the Pediatric ICU, NICU or CTICU.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Interventions

Neuromuscular Blockade

Intervention Hierarchy (Ancestors)

Anesthesia and AnalgesiaInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 8, 2013

Study Start

February 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 2, 2016

Record last verified: 2016-11

Locations