Frequency of Residual Neuromuscular Blockade in the Pediatric Population

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

Study Overview

• Status: Terminated
• Conditions: Neuromuscular Blockade
• Intervention / Treatment: Procedure: Neuromuscular blockade

Detailed Description

The proposed study will be the first to investigate the incidence of residual postoperative neuromuscular blockade in the pediatric patient following the intraoperative use of NMBA's. If there is significant residual blockade present, it may be that these effects will lead to postoperative respiratory complications including hypoxemia, atelectasis, and prolonged oxygen requirement resulting in a prolonged stay in the post-anesthesia care unit.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery that requires them to be paralyzed

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neuromuscular blockade	Procedure: Neuromuscular blockade

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
train-of-four (TOF) ratio	TOF ratio shows the residual of neuromuscular agents.	1 day

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Estimate): December 2, 2016
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: IRB13-00045