Postoperative Residual CurarizationNCT03665805
Postoperative Residual Curarization in 2018
An observational study of Postoperative Residual Curarization, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
Trial summary
The primary objective of this study is to evaluate the incidence of postoperative residual curarization, as defined by a train-of-four <90%, upon postanaesthesia care unit arrival. Anesthetists tend to use train-of-four monitoring in the operating theatre to interpret muscle tone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Residual Curarization
- What is being tested?
- neuromuscular transmission monitoring
- How many people
- 587 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jul 2018to 12 Nov 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: About 600 surgical patients (the first 600 inpatients and outpatients scheduled for anesthesia during the study period who meet the study criteria).
Who may be able to join
- 18 years of age or older;
- Informed consent signed;
- Admission for elective surgery;
- Administration of non-depolarizing neuromuscular blocking agents during surgery;
- Tracheal intubation
Who cannot join
- Evidence of renal, hepatic, metabolic, and/or neuromuscular disorders
- Ejection fraction <20%
- Admission for emergency surgery; or cardiothoracic surgery
- Reoperation during the same hospital admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromuscular Monitoring, Reversal of Block and Postoperative Residual Curarization: the Situation in 2018
The primary objective of this study is to evaluate the incidence of postoperative residual curarization, as defined by a train-of-four <90%, upon postanaesthesia care unit arrival. Anesthetists tend to use train-of-four monitoring in the operating theatre to interpret muscle tone. Train-of-four monitoring is a widely used term for the peripheral nerve stimulation used in neuromuscular blockade monitoring. Hypothesizing a change in our practice since 2006-2012 (Cammu G, Anesth Analg 2006; 102: 426-9 and Cammu G, Anaesth Intensive Care 2012; 40: 999-1006), residual neuromuscular block as well as the use of intraoperative neuromuscular transmission monitoring and reversal of neuromuscular blocking agents will again be prospectively evaluated in 2018. The present study aims to compare these three periods (2006-2012-2018) in terms of management of neuromuscular block in the operating room and to look for a relationship with the incidence of postoperative residual curarization.
- Conditions
- Postoperative Residual Curarization
- Being tested
- neuromuscular transmission monitoring
- Keywords
- Muscle Relaxation
- 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.
neuromuscular transmission monitoringOther
The acceleromyographic responses of the adductor pollicis muscle as percent of the train-of-four (TOF%) on stimulation of the ulnar nerve by means of the TOFscan neuromuscular transmission monitor (iDMed, Marseille, France).
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative residual curarisation
Incidence of postoperative residual curarisation defined by a train-of-four (TOF) ratio < 0,9 at post-anesthesia care unit arrival
Measured: Immediately after the patients' arrival in the post-anesthesia care unit (<5 min after arrival), two consecutive neuromuscular transmission measurements (separated by 15 s) will be obtained, and the average of the 2 values will be recorded.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start30 Jul 2018
- Primary completion31 Oct 2018
- Study completion12 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy CAMMU, Onze Lieve Vrouw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665805
- Sponsor's protocol ID
- LKGC2018
- Status last verified
- Nov 2018
- First submitted
- 7 Sep 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cammu G, De Witte J, De Veylder J, Byttebier G, Vandeput D, Foubert L, Vandenbroucke G, Deloof T. Postoperative residual paralysis in outpatients versus inpatients. Anesth Analg. 2006 Feb;102(2):426-9. doi: 10.1213/01.ane.0000195543.61123.1f.
PubMed 16428537Cammu GV, Smet V, De Jongh K, Vandeput D. A prospective, observational study comparing postoperative residual curarisation and early adverse respiratory events in patients reversed with neostigmine or sugammadex or after apparent spontaneous recovery. Anaesth Intensive Care. 2012 Nov;40(6):999-1006. doi: 10.1177/0310057X1204000611.
PubMed 23194209
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Monitoring, Reversal of Block and Postoperative Residual Curarization: the Situation in 2018
- ClinicalTrials.gov ID
- NCT03665805
- Acronym / sponsor ID
- LKGC2018
- Conditions
- Postoperative Residual Curarization
- Keywords
- Muscle Relaxation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- Onze Lieve Vrouw HospitalUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 11 Sep 2018 (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 objective of this study is to evaluate the incidence of postoperative residual curarization, as defined by a train-of-four <90%, upon postanaesthesia care unit arrival. Anesthetists tend to use train-of-four monitoring in the operating theatre to interpret muscle tone. Train-of-four monitoring is a widely used term for the peripheral nerve stimulation used in neuromuscular blockade monitoring. Hypothesizing a change in our practice since 2006-2012 (Cammu G, Anesth Analg 2006; 102: 426-9 and Cammu G, Anaesth Intensive Care 2012; 40: 999-1006), residual neuromuscular block as well as the use of intraoperative neuromuscular transmission monitoring and reversal of neuromuscular blocking agents will again be prospectively evaluated in 2018. The present study aims to compare these three periods (2006-2012-2018) in terms of management of neuromuscular block in the operating room and to look for a relationship with the incidence of postoperative residual curarization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- About 600 surgical patients (the first 600 inpatients and outpatients scheduled for anesthesia during the study period who meet the study criteria).
Key inclusion criteria (5 listed)
- 18 years of age or older;
- Informed consent signed;
- Admission for elective surgery;
- Administration of non-depolarizing neuromuscular blocking agents during surgery;
- Tracheal intubation
Key exclusion criteria (4 listed)
- Evidence of renal, hepatic, metabolic, and/or neuromuscular disorders
- Ejection fraction <20%
- Admission for emergency surgery; or cardiothoracic surgery
- Reoperation during the same hospital admission
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 transmission monitoringThe acceleromyographic responses of the adductor pollicis muscle as percent of the train-of-four (TOF%) on stimulation of the ulnar nerve by means of the TOFscan neuromuscular transmission monitor (iDMed, Marseille, France). | Other | – |
Primary outcome
Incidence of postoperative residual curarisation
Time frame: Immediately after the patients' arrival in the post-anesthesia care unit (<5 min after arrival), two consecutive neuromuscular transmission measurements (separated by 15 s) will be obtained, and the average of the 2 values will be recorded.
Incidence of postoperative residual curarisation defined by a train-of-four (TOF) ratio < 0,9 at post-anesthesia care unit arrival
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 14 Nov 2018.
- Background: PubMed 16428537Cammu G, De Witte J, De Veylder J, Byttebier G, Vandeput D, Foubert L, Vandenbroucke G, Deloof T. Postoperative residual paralysis in outpatients versus inpatients. Anesth Analg. 2006 Feb;102(2):426-9. doi: 10.1213/01.ane.0000195543.61123.1f.
- Background: PubMed 23194209Cammu GV, Smet V, De Jongh K, Vandeput D. A prospective, observational study comparing postoperative residual curarisation and early adverse respiratory events in patients reversed with neostigmine or sugammadex or after apparent spontaneous recovery. Anaesth Intensive Care. 2012 Nov;40(6):999-1006. doi: 10.1177/0310057X1204000611.
- Individual participant dataSharing planned: No
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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.
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 Postoperative Residual Curarization, run by Onze Lieve Vrouw Hospital at 1 site in Belgium.
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 5 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 14 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 Belgium. 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?
Incidence of postoperative residual curarisation (time frame: Immediately after the patients' arrival in the post-anesthesia care unit (<5 min after arrival), two consecutive neuromuscular transmission measurements (separated by 15 s) will be obtained, and the average of the 2 values will be recorded.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03665805, which also lists 2 linked publications.
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 14 Nov 2018.