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Residual Neuromuscular Blockade in Pediatric Anesthesia (REPEB)

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ClinicalTrials.gov Identifier: NCT02939911
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Petr Štourač, MD, 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).

Condition or disease Intervention/treatment
Residual Neuromuscular Blockade Device: Residual neuromuscular blockade measurement

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.

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Study Type : Observational
Actual Enrollment : 291 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Residual Neuromuscular Blockade in Paediatric Patients Before Extubation and in Postanesthetic Care Unit:Prospective Observational Cohort Study
Study Start Date : January 2017
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Group/Cohort Intervention/treatment
Paediatric patients after NMBA administration
Paediatric patients undergoing surgery with neuromuscular blockade
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
Other Name: accelerometry




Primary Outcome Measures :
  1. Early residual neuromuscular blockade [ Time Frame: before extubation ]
    Just prior extubation the residual neuromuscular blockade will be measured by accelerometry


Secondary Outcome Measures :
  1. Late neuromuscular blockade [ Time Frame: at arrival to PACU ]
    At the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry



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Ages Eligible for Study:   29 Weeks to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Paediatric patients undergoing surgery with neuromuscular blocking agents were administered
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939911


Locations
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Czechia
Brno University Hospital
Brno, Czechia, 62500
Sponsors and Collaborators
Brno University Hospital

Additional Information:
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Responsible Party: Petr Štourač, MD, doc.MD.Ph.D, Brno University Hospital
ClinicalTrials.gov Identifier: NCT02939911     History of Changes
Other Study ID Numbers: KDAR FN Brno 2016/2
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Petr Štourač, MD, Brno University Hospital:
Residual neuromuscular blockade

Additional relevant MeSH terms:
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Delayed Emergence from Anesthesia
Postoperative Complications
Pathologic Processes