Neuromuscular BlockadePAMPENCT03086915
Myorelaxation Practice in Paediatric Anesthesia
An observational study of Neuromuscular Blockade, run by Brno University Hospital at 1 site in Czechia.
Trial summary
In retrospective data search the investigators will identified the percentage of patients with muscle relaxants administered during perioperative period. The block reversal, typ of drug, percentage of cases with and without reversal will be identified. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Neuromuscular Blocking Agent
- How many people
- 1,650 participants
- Where
- 1 siteCzechia
- Study dates
- 5 Mar 2017to 1 Aug 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 Up to 20 years
- All sexes
- Child, Adult
Study population: Paediatric anesthesiology patients who underwent surgery with neuromuscular blocking agent administered during surgery in tertiary center paediatric anesthesiology department
Who may be able to join
- paediatric patients
- the study period (1/2016-12/2016)
- neuromuscular blocking agent administration during surgery
Who cannot join
- surgery without neuromuscular blockade
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Myorelaxation Practice in Paediatric Anesthesia: Retrospective Study
In retrospective data search the investigators will identified the percentage of patients with muscle relaxants administered during perioperative period. The block reversal, typ of drug, percentage of cases with and without reversal will be identified.
Read the detailed description
The actual percentage of surgeries with the muscle relaxants administered during perioperative period in paediatric patients remain unclear because many surgeries are being performed without muscle relaxation. In this retrospective study, the anesthesiology perioperative data from January 2016 till December 2016 in the tertiary center od Pediatric anesthesia will be searched for the percentage of surgeries with muscle relaxants administered. Type of surgery, age, weight, duration u surgery, muscle relaxants drug and percentage of block reversal will be identified.
- Conditions
- Neuromuscular Blockade
- Being tested
- Neuromuscular Blocking Agent
- Keywords
- neuromuscular blockade, muscle relaxation, muscle relaxant
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular Blocking AgentDrug
Administration of neuromuscular blockers during anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Patients with neuromuscular block | Neuromuscular blocking agent administrated during surgery to the paediatric patient Receives: Drug: Neuromuscular Blocking Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of neuromuscular block reversal
The actual percentage of paediatric patients with perioperative neuromuscular blockade with active pharmacology block reversal at the end of surgery
Measured: 1 year
Secondary outcomes (2)
Percentage of surgeries without muscle relaxant administration
Paediatric surgeries without neuromuscular blocking agent administration
Measured: 1 year
Type of neuromuscular blocking agent in paediatric anesthesiology practice
Actual type of neuromuscular blocking agent used in paediatric anesthesiology practice in predefined period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start5 Mar 2017
- Primary completion30 Jul 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 1,650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03086915
- Sponsor's protocol ID
- KDAR FN Brno 3/2017
- Acronym
- PAMPE
- Status last verified
- Nov 2018
- First submitted
- 5 Mar 2017
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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
- Myorelaxation Practice in Paediatric Anesthesia: Retrospective Study
- ClinicalTrials.gov ID
- NCT03086915
- Acronym / sponsor ID
- PAMPE / KDAR FN Brno 3/2017
- Conditions
- Neuromuscular Blockade
- Keywords
- neuromuscular blockade, muscle relaxation, muscle relaxant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,650 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 5 Mar 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 22 Mar 2017 (actual)
- 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.
In retrospective data search the investigators will identified the percentage of patients with muscle relaxants administered during perioperative period. The block reversal, typ of drug, percentage of cases with and without reversal will be identified.
Detailed description
The actual percentage of surgeries with the muscle relaxants administered during perioperative period in paediatric patients remain unclear because many surgeries are being performed without muscle relaxation. In this retrospective study, the anesthesiology perioperative data from January 2016 till December 2016 in the tertiary center od Pediatric anesthesia will be searched for the percentage of surgeries with muscle relaxants administered. Type of surgery, age, weight, duration u surgery, muscle relaxants drug and percentage of block reversal will be identified.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with neuromuscular block | – | Drug: Neuromuscular Blocking AgentNeuromuscular blocking agent administrated during surgery to the paediatric patient |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Paediatric anesthesiology patients who underwent surgery with neuromuscular blocking agent administered during surgery in tertiary center paediatric anesthesiology department
Key inclusion criteria (3 listed)
- paediatric patients
- the study period (1/2016-12/2016)
- neuromuscular blocking agent administration during surgery
Key exclusion criteria (1 listed)
- surgery without neuromuscular blockade
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 |
|---|---|---|
| Neuromuscular Blocking AgentAdministration of neuromuscular blockers during anesthesia | Drug | Patients with neuromuscular block |
Primary outcome
Percentage of neuromuscular block reversal
Time frame: 1 year
The actual percentage of paediatric patients with perioperative neuromuscular blockade with active pharmacology block reversal at the end of surgery
2 secondary outcomes
Percentage of surgeries without muscle relaxant administration
Time frame: 1 year
Type of neuromuscular blocking agent in paediatric anesthesiology practice
Time frame: 1 year
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 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 3 inclusion and 1 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?
Percentage of neuromuscular block reversal (time frame: 1 year). 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.