Postoperative Residual CurarizationI-PORCNCT03804346
Infantile - Postoperative Residual Curarization - Study
An observational study of Postoperative Residual Curarization and Neuromuscular Blockade, run by University of Regensburg at 1 site in Germany.
Trial summary
The primary object of this study is, to investigate the current procedure of neuromuscular monitoring at a tertiary academic university medical center. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Residual Curarization, Neuromuscular Blockade, Neuromuscular Monitoring
- What is being tested?
- Acceleromyography
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2017to 23 Jul 2017
- How long will I take part?
- 1 Day
- 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 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All children/youths between 1 Month to 18 years who are undergoing general anaesthesia with muscle relaxation due to surgical or diagnostical procedures.
Who may be able to join
- General aneasthesia with muscle relaxation
- Children between 1 Month to 18 Years
- Endotracheal Intubation due to surgical or diagnostical procedures
Who cannot join
- older than 18 years
- local aneasthesia
- regional aneasthesia
- larynx mask
- patient comes from ICU
- children who are not planned to be extubated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Detect Postoperative Residual Curarization in Infantile Patients
The primary object of this study is, to investigate the current procedure of neuromuscular monitoring at a tertiary academic university medical center.
Read the detailed description
Residual neuromuscular block is known to be a significant but frequently overlooked complication after the use of neuromuscular blocking agents. Aim of this prospective, observational study is to detect the incidence and severity of residual paralysis at a tertiary academic german university medical center.
Methods:
All infantile patients recieving neuromuscular blocking agents are included over a 12 week observational period. At the end of the operation procedure, directly prior to tracheal extubation a train-of-four ratio was assessed quantitatively by an independet observer using the TOF Watch SX monitor. Data related to patient postoperative outcome were collected in the operating theatre, during the way to the postoperative care unit (PACU) and during the stay in the PACU:
- incidence of residual paralysis
- incidence of aspiration, bronchospasm, laryngospasm, oxygen desaturation, airway obstruction,
- Being tested
- Acceleromyography
- 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.
AcceleromyographyDiagnostic test
At the End of Surgery, shortly before Extubation, the TOF-Ratio is measured by an independent investigator using Acceleromyography.
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual paralysis
Rate of residual paralysis after extubation of the infantile patients measured by acceleromyography.
Measured: Directly prior to extubation
Secondary outcomes (3)
Airway obstruction
Clinical assessment of the upper airway
Measured: 1, 10, 30, 60 minutes after extubation
Oxygen desaturation
Measurement of the oxygen saturation by pulse oxymetry
Measured: 1, 10, 30, 60 minutes after extubation
Bronchospasm, laryngospasm
Clinical assessment the airway
Measured: 1, 10, 30, 60 minutes after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start1 May 2017
- Primary completion23 Jul 2017
- Study completion23 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Residual CurarizationStudies 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
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Unterbuchner, University of Regensburg
- Investigators
- Christoph Unterbuchner, MD, Principal investigator, University medical center Regensburg, Department of anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804346
- Sponsor's protocol ID
- 17-449-101
- Acronym
- I-PORC
- Status last verified
- Jan 2019
- First submitted
- 1 Dec 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Detect Postoperative Residual Curarization in Infantile Patients
- ClinicalTrials.gov ID
- NCT03804346
- Acronym / sponsor ID
- I-PORC / 17-449-101
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 23 Jul 2017 (actual)
- Study completion
- 23 Jul 2017 (actual)
- First posted
- 15 Jan 2019 (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.
The primary object of this study is, to investigate the current procedure of neuromuscular monitoring at a tertiary academic university medical center.
Detailed description
Residual neuromuscular block is known to be a significant but frequently overlooked complication after the use of neuromuscular blocking agents. Aim of this prospective, observational study is to detect the incidence and severity of residual paralysis at a tertiary academic german university medical center.
Methods:
All infantile patients recieving neuromuscular blocking agents are included over a 12 week observational period. At the end of the operation procedure, directly prior to tracheal extubation a train-of-four ratio was assessed quantitatively by an independet observer using the TOF Watch SX monitor. Data related to patient postoperative outcome were collected in the operating theatre, during the way to the postoperative care unit (PACU) and during the stay in the PACU:
- incidence of residual paralysis
- incidence of aspiration, bronchospasm, laryngospasm, oxygen desaturation, airway obstruction,
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All children/youths between 1 Month to 18 years who are undergoing general anaesthesia with muscle relaxation due to surgical or diagnostical procedures.
Key inclusion criteria (3 listed)
- General aneasthesia with muscle relaxation
- Children between 1 Month to 18 Years
- Endotracheal Intubation due to surgical or diagnostical procedures
Key exclusion criteria (6 listed)
- older than 18 years
- local aneasthesia
- regional aneasthesia
- larynx mask
- patient comes from ICU
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 |
|---|---|---|
| AcceleromyographyAt the End of Surgery, shortly before Extubation, the TOF-Ratio is measured by an independent investigator using Acceleromyography. | Diagnostic test | – |
Primary outcome
Residual paralysis
Time frame: Directly prior to extubation
Rate of residual paralysis after extubation of the infantile patients measured by acceleromyography.
3 secondary outcomes
Airway obstruction
Time frame: 1, 10, 30, 60 minutes after extubation
Oxygen desaturation
Time frame: 1, 10, 30, 60 minutes after extubation
Bronchospasm, laryngospasm
Time frame: 1, 10, 30, 60 minutes after extubation
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 15 Jan 2019.
Related trials for Postoperative Residual Curarization
Not yet recruitingObservational study
Postoperative Residual Neuromuscular Block and Passive Smoke Exposure in Pediatric Dental Patients
Postoperative Residual Curarization, Neuromuscular Block Prolonged
Not yet recruitingObservational study
Acceleromyography Versus Electromyography for Neuromuscular Recovery Assessment at the End of Surgery
Neuromuscular Blockade, Cholecystectomy
Recruiting
Impact of Sugammadex Versus Neostigmine on Early Postoperative Pulmonary Function
Residual Neuromuscular Block
RecruitingObservational study
Comparison of an Acceleromyography- and Electromyography-based Neuromuscular Monitor With TOF-Watch ® Monitor
Neuromuscular Blockade
Not yet recruitingPhase 4
A Dose-response Study to Determine the Right Dosage of Sugammadex as a Reversal Agent of Rocuronium in Infants Between 1 and 24 Months Old
Curarization, Postoperative Residual
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.
Christoph Unterbuchner, MD principal investigator
University medical center Regensburg, Department of anaesthesiology
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 Postoperative Residual Curarization and Neuromuscular Blockade, run by University of Regensburg at 1 site in Germany.
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 6 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 15 Jan 2019. 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 Germany. 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?
Residual paralysis (time frame: Directly prior to 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 15 Jan 2019.