- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03086915
Myorelaxation Practice in Paediatric Anesthesia (PAMPE)
November 16, 2018 updated by: Petr Štourač, MD, Brno University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
1650
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brno, Czechia, 62500
- Brno University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 20 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Paediatric anesthesiology patients who underwent surgery with neuromuscular blocking agent administered during surgery in tertiary center paediatric anesthesiology department
Description
Inclusion Criteria:
- paediatric patients
- the study period (1/2016-12/2016)
- neuromuscular blocking agent administration during surgery
Exclusion Criteria:
- surgery without neuromuscular blockade
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with neuromuscular block
Neuromuscular blocking agent administrated during surgery to the paediatric patient
|
Administration of neuromuscular blockers during anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of surgeries without muscle relaxant administration
Time Frame: 1 year
|
Paediatric surgeries without neuromuscular blocking agent administration
|
1 year
|
|
Type of neuromuscular blocking agent in paediatric anesthesiology practice
Time Frame: 1 year
|
Actual type of neuromuscular blocking agent used in paediatric anesthesiology practice in predefined period.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 5, 2017
Primary Completion (Actual)
July 30, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
March 5, 2017
First Submitted That Met QC Criteria
March 16, 2017
First Posted (Actual)
March 22, 2017
Study Record Updates
Last Update Posted (Actual)
November 19, 2018
Last Update Submitted That Met QC Criteria
November 16, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KDAR FN Brno 3/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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