Residual Neuromuscular Blockade in Pediatric Anesthesia

Residual Neuromuscular Blockade Clinical Trial

— REPEB  

Official title:

Residual Neuromuscular Blockade in Paediatric Patients Before Extubation and in Postanesthetic Care Unit:Prospective Observational Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02939911
• Other study ID #: KDAR FN Brno 2016/2
• Status: Completed
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: November 2018
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Description:

Residual neuromuscular blockade (RNB) is frequent and it is associated with negative impact on postoperative morbidity and mortality. The incidence of the RNB in adult is well described, however in pediatric subpopulation it 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). In the trial will be enrolled all pediatric patients (28 weeks of age and older - 19 years old) whom will be administered neuromuscular blocking agent during anesthesia. The demographic data will be collected including: age, weight, type of surgery, ASA status. The anesthesia management will be described including: airway management, type and cumulative dose of neuromuscular blocking agent (NMBA) and time and dose of the last administered bolus of NMBA. The residual neuromuscular blockade will be measured according to the standards: TOF Watch accelerometry at the moment prior to extubation (two measurements) in TOF mode and at the arrival to postanesthetic care unit (PACU) (two measurements) in TOF mode.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Weeks to 19 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• weight under 3000 grams

• neuromuscular disease

• haemodynamic impairment (vasopressor need)

• planned postoperative mechanical ventilation

Related Conditions & MeSH terms

• Delayed Emergence from Anesthesia
• Residual Neuromuscular Blockade

Intervention

Device:
• Residual neuromuscular blockade measurement
Just prior extubation in OR and at the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early residual neuromuscular blockade	Just prior extubation the residual neuromuscular blockade will be measured by accelerometry	before extubation
Secondary	Late neuromuscular blockade	At the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry	at arrival to PACU

External Links

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