Neuromuscular BlockadeNCT01786863
Frequency of Residual Neuromuscular Blockade in the Pediatric Population
An observational study of Neuromuscular Blockade, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This study is designed to investigate the frequency of Residual Neuromuscular Blockade (RNMB) in the pediatric population. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- Neuromuscular blockade
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2015
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients undergoing surgery that requires them to be paralyzed
Who may be able to join
- Age less than 18 years.
- Surgery requiring the administration of neuromuscular blocking, agents with planned extubation in the postoperative care unit (PACU).
Who cannot join
- Neuromuscular diseases which may prolong the duration of NMBA's or exaggerate the effects of residual blockade.
- The need for postoperative mechanical ventilation.
- Direct admission to the Pediatric ICU, NICU or CTICU.
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to investigate the frequency of Residual Neuromuscular Blockade (RNMB) in the pediatric population.
Read the detailed description
The proposed study will be the first to investigate the incidence of residual postoperative neuromuscular blockade in the pediatric patient following the intraoperative use of NMBA's. If there is significant residual blockade present, it may be that these effects will lead to postoperative respiratory complications including hypoxemia, atelectasis, and prolonged oxygen requirement resulting in a prolonged stay in the post-anesthesia care unit.
- Conditions
- Neuromuscular Blockade
- Being tested
- Neuromuscular blockade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular blockadeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular blockade | Not described Receives: Procedure: Neuromuscular blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
train-of-four (TOF) ratio
TOF ratio shows the residual of neuromuscular agents.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: PI returned to her home country of Japan
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.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiromi Kako, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786863
- Sponsor's protocol ID
- IRB13-00045
- Status last verified
- Nov 2016
- First submitted
- 6 Feb 2013
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Residual Neuromuscular Blockade in the Pediatric Population
- ClinicalTrials.gov ID
- NCT01786863
- Acronym / sponsor ID
- IRB13-00045
- Conditions
- Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI returned to her home country of Japan
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Feb 2013 (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.
This study is designed to investigate the frequency of Residual Neuromuscular Blockade (RNMB) in the pediatric population.
Detailed description
The proposed study will be the first to investigate the incidence of residual postoperative neuromuscular blockade in the pediatric patient following the intraoperative use of NMBA's. If there is significant residual blockade present, it may be that these effects will lead to postoperative respiratory complications including hypoxemia, atelectasis, and prolonged oxygen requirement resulting in a prolonged stay in the post-anesthesia care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular blockade | – | Procedure: Neuromuscular blockade |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients undergoing surgery that requires them to be paralyzed
Key inclusion criteria (2 listed)
- Age less than 18 years.
- Surgery requiring the administration of neuromuscular blocking, agents with planned extubation in the postoperative care unit (PACU).
Key exclusion criteria (3 listed)
- Neuromuscular diseases which may prolong the duration of NMBA's or exaggerate the effects of residual blockade.
- The need for postoperative mechanical ventilation.
- Direct admission to the Pediatric ICU, NICU or CTICU.
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 blockade | Procedure or surgery | Neuromuscular blockade |
Primary outcome
train-of-four (TOF) ratio
Time frame: 1 day
TOF ratio shows the residual of neuromuscular agents.
Results and safety
The study was stopped early (reason given: PI returned to her home country of Japan). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
Related trials for Neuromuscular Blockade
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Inspiratory Muscle Training and Diaphragmatic Breathing in GAD
Generalized Anxiety Disorder (GAD)
Not yet recruiting
Comparative Effects Of Exercises Targeting Upper Trapezius In Patients With Non Specific Neck Pain
Non Specific Neck Pain
RecruitingObservational study
The Association Between Residual Neuromuscular Block Risk Prediction Score and the Train-of-Four Ratio
Muscle Relaxants
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 Nationwide Children's Hospital at 1 site in United States.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 2 Dec 2016. 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 United States. 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 was stopped early (reason given: PI returned to her home country of Japan). Results are not available in the source record.
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?
train-of-four (TOF) ratio (time frame: 1 day). 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 2 Dec 2016.