Frequency of Residual Neuromuscular Blockade in the Pediatric Population

Neuromuscular Blockade Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01786863
• Other study ID #: IRB13-00045
• Status: Terminated
• Phase: N/A
• First received: February 6, 2013
• Last updated: November 30, 2016
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Neuromuscular Blockade

Intervention

Procedure:
• Neuromuscular blockade

Locations

Country	Name	City	State
United States	Nationwide Children's	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	train-of-four (TOF) ratio	TOF ratio shows the residual of neuromuscular agents.	1 day	No