Residual Neuromuscular BlockadeREPEBNCT02939911
Residual Neuromuscular Blockade in Pediatric Anesthesia
An observational study of Residual Neuromuscular Blockade, run by Brno University Hospital at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 29 weeks to 19 years
- Conditions the study is for
- Residual Neuromuscular Blockade
- What is being tested?
- Residual neuromuscular blockade measurement
- Type of treatment
- Medical device
- How many people
- 291 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2017to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 weeks to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Paediatric patients undergoing surgery with neuromuscular blocking agents were administered
Who may be able to join
- Paediatric patients undergoing surgery with neuromuscular blocking agents were administered with the age limits
Who cannot join
- weight under 3000 grams
- neuromuscular disease
- haemodynamic impairment (vasopressor need)
- planned postoperative mechanical ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Residual Neuromuscular Blockade in Paediatric Patients Before Extubation and in Postanesthetic Care Unit:Prospective Observational Cohort Study
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).
Read the 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
- Being tested
- Residual neuromuscular blockade measurement
- Keywords
- Residual neuromuscular blockade
- Medical subject headings
- Delayed Emergence from Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Residual neuromuscular blockade measurementDevice
Also called accelerometry
Just prior extubation in OR and at the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry
| Study group | Role | What they receive |
|---|---|---|
| Paediatric patients after NMBA administration | Paediatric patients undergoing surgery with neuromuscular blockade Receives: Device: Residual neuromuscular blockade measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early residual neuromuscular blockade
Just prior extubation the residual neuromuscular blockade will be measured by accelerometry
Measured: before extubation
Secondary outcomes (1)
Late neuromuscular blockade
At the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry
Measured: at arrival to PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Residual Neuromuscular BlockadeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02939911
- Sponsor's protocol ID
- KDAR FN Brno 2016/2
- Acronym
- REPEB
- Status last verified
- Nov 2018
- First submitted
- 18 Oct 2016
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Neuromuscular Blockade in Paediatric Patients Before Extubation and in Postanesthetic Care Unit:Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT02939911
- Acronym / sponsor ID
- REPEB / KDAR FN Brno 2016/2
- Conditions
- Residual Neuromuscular Blockade
- Keywords
- Residual neuromuscular blockade
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paediatric patients after NMBA administration | – | Device: Residual neuromuscular blockade measurementPaediatric patients undergoing surgery with neuromuscular blockade |
Who may qualify
- Ages
- 29 weeks to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Paediatric patients undergoing surgery with neuromuscular blocking agents were administered
Key inclusion criteria (1 listed)
- Paediatric patients undergoing surgery with neuromuscular blocking agents were administered with the age limits
Key exclusion criteria (4 listed)
- weight under 3000 grams
- neuromuscular disease
- haemodynamic impairment (vasopressor need)
- planned postoperative mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Residual neuromuscular blockade measurementAlso: accelerometryJust prior extubation in OR and at the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry | Device | Paediatric patients after NMBA administration |
Primary outcome
Early residual neuromuscular blockade
Time frame: before extubation
Just prior extubation the residual neuromuscular blockade will be measured by accelerometry
1 secondary outcome
Late neuromuscular blockade
Time frame: at arrival to PACU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Residual Neuromuscular Blockade, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early residual neuromuscular blockade (time frame: before extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.