Residual Neuromuscular Blockade in Pediatric Anesthesia

Completed

• Conditions: Residual Neuromuscular Blockade

• Registration Number: NCT02939911
• Lead Sponsor: Brno University Hospital

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-18
• Study First Posted: 2016-10-20
• Study Start: 2017-01
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Early residual neuromuscular blockade	before extubation	Just prior extubation the residual neuromuscular blockade will be measured by accelerometry

Secondary Outcome Measures

Name	Time	Method
Late neuromuscular blockade	at arrival to PACU	At the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry

Trial Locations

Locations (1)

Brno University Hospital; 🇨🇿 Brno, Czechia