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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

Tracking Information
First Submitted Date October 18, 2016
First Posted Date October 20, 2016
Last Update Posted Date November 19, 2018
Study Start Date January 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 20, 2016)
Early residual neuromuscular blockade [ Time Frame: before extubation ]
Just prior extubation the residual neuromuscular blockade will be measured by accelerometry
Original Primary Outcome Measures
 (submitted: October 18, 2016)
Early residual neuromuscular blockade [ Time Frame: 6 months ]
Just prior extubation the residual neuromuscular blockade will be measured by accelerometry
Change History Complete list of historical versions of study NCT02939911 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 20, 2016)
Late neuromuscular blockade [ Time Frame: at arrival to PACU ]
At the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry
Original Secondary Outcome Measures
 (submitted: October 18, 2016)
Late neuromuscular blockade [ Time Frame: 6 months ]
At the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Residual Neuromuscular Blockade in Pediatric Anesthesia
Official Title Residual Neuromuscular Blockade in Paediatric Patients Before Extubation and in Postanesthetic Care Unit:Prospective Observational Cohort Study
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Paediatric patients undergoing surgery with neuromuscular blocking agents were administered
Condition 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
Other Name: accelerometry
Study Groups/Cohorts Paediatric patients after NMBA administration
Paediatric patients undergoing surgery with neuromuscular blockade
Intervention: Device: Residual neuromuscular blockade measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 12, 2018)
291
Original Estimated Enrollment
 (submitted: October 18, 2016)
200
Actual Study Completion Date December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 29 Weeks to 19 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Czechia
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number NCT02939911
Other Study ID Numbers KDAR FN Brno 2016/2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Petr Štourač, MD, Brno University Hospital
Study Sponsor Brno University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Brno University Hospital
Verification Date November 2018