Residual Neuromuscular Blockade in Pediatric Anesthesia

NCT ID: NCT02939911

Last Updated: 2018-11-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 291 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Residual Neuromuscular Blockade

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Paediatric patients after NMBA administration

Paediatric patients undergoing surgery with neuromuscular blockade

Residual neuromuscular blockade measurement

Intervention Type: DEVICE

Just prior extubation in OR and at the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry

Interventions

Residual neuromuscular blockade measurement

Just prior extubation in OR and at the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry

Intervention Type: DEVICE

Other Intervention Names

accelerometry

Eligibility Criteria

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

• Minimum Eligible Age: 29 Weeks
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Petr Štourač, MD

doc.MD.Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brno University Hospital

Brno, , Czechia

Countries

Czechia

Other Identifiers

KDAR FN Brno 2016/2

Identifier Type: -

Identifier Source: org_study_id