Neuromuscular BlockadeNCT02914119

Use of Neuromuscular Blocking Agents and Neuromuscular Monitoring in 7 Danish Teaching Hospitals

An observational study of Neuromuscular Blockade, run by Jakob Louis Thomsen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Aim: To explore the frequency of use of objective neuromuscular monitoring for assessment of depth of neuromuscular blockade in general anaesthesia the incidence of residual neuromuscular blockade, and the timing of reversal of the neuromuscular blockade at the end of anaesthesia. Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Neuromuscular Blockade
What is being tested?: Rocuronium, Succinylcholine and Cisatracurium
Type of treatment: Medical device
How many people: 30,430 participants
Where: 1 siteDenmark
Study dates: 1 Oct 2016to 1 Jun 2017
How long will I take part?: 1 Day
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients who received general anaesthesia with neuromuscular blockade

Who may be able to join

Patients who received general anaesthesia with neuromuscular blockade in one of the 7 hospitals providing data for the study in the last 18 months up until the time of data collection

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Herlev Hospital
Herlev

Other trials in Denmark

About this study

Official title: Use of Neuromuscular Blocking Agents and Neuromuscular Monitoring in 7 Danish Teaching Hospitals - a Cross-sectional Study

Aim: To explore

the frequency of use of objective neuromuscular monitoring for assessment of depth of neuromuscular blockade in general anaesthesia
the incidence of residual neuromuscular blockade, and
the timing of reversal of the neuromuscular blockade at the end of anaesthesia.

We will collect data from 7 Danish anaesthesia departments, using data from the Anaesthesia Information Management System (AIMS).

Conditions: Neuromuscular Blockade
Being tested: Rocuronium, Succinylcholine, Cisatracurium, Mivacurium, Objective neuromuscular monitoring (acceleromyography)
Keywords: Residual nerve blockade, Neuromuscular monitoring, Residual curarization, Neuromuscular blocking agents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RocuroniumDrug
SuccinylcholineDrug
CisatracuriumDrug
MivacuriumDrug
Objective neuromuscular monitoring (acceleromyography)Device
SugammadexDrug
NeostigmineDrug

Study groups in NCT02914119
Study group	Role	What they receive
Eligible patients		Patients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection. Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received. Receives: Drug: Rocuronium; Drug: Succinylcholine; Drug: Cisatracurium; Drug: Mivacurium; Device: Objective neuromuscular monitoring (acceleromyography); Drug: Sugammadex; Drug: Neostigmine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no)
Measured: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no)
Measured: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours

Secondary outcomes (6)

Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA
The train-of-four (TOF) ratio is the ratio between the last and first measurements after four stimuli of the ulnar nerve at 2 Hz. The ratio should be at least 0.9 before tracheal extubation.
Measured: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Number of Participants With and Without Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no)
Measured: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Number of Participants With and Without Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no)
Measured: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Time in Minutes From Tracheal Extubation or Removal of Supraglottic Airway Device to Discharge From Post-anaesthesia Care Unit in Cases Involving a Non-depolarizing NMBA With and Without Neuromuscular Monitoring, Respectively
Measured: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes
Number of Participants With and Without Mild Oxygen Desaturation (<90%, But >80%) in Cases Receiving a Non-depolarizing NMBA
Measured: in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours
Number of Participants With and Without Severe Oxygen Desaturation (<80%) in Cases Receiving a Non-depolarizing NMBA
Measured: in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20161 Jun 2017

First posted26 Sep 2016 (estimated)
Study start1 Oct 2016
Primary completion1 Jun 2017
Study completion1 Jun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Other
Time perspective: Cross-sectional
Enrolment: 30,430 participants (actual)
Target duration: 1 Day

IDs, dates and publications

ClinicalTrials.gov ID: NCT02914119
Sponsor's protocol ID: JLT-NM4
Status last verified: Aug 2019
First submitted: 9 Sep 2016
Last updated: 12 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: Sharing of data not included in the permissions granted by authorities stated below

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
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All Neuromuscular Blockade trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Neuromuscular Blocking Agents and Neuromuscular Monitoring in 7 Danish Teaching Hospitals - a Cross-sectional Study
ClinicalTrials.gov ID: NCT02914119
Acronym / sponsor ID: JLT-NM4
Conditions: Neuromuscular Blockade
Keywords: Residual nerve blockade, Neuromuscular monitoring, Residual curarization, Neuromuscular blocking agents
Study type: Observational
Recruitment status: Completed
Enrolment: 30,430 participants (actual)
Lead sponsor: Jakob Louis ThomsenUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: 1 Oct 2016 (actual)
Primary completion: 1 Jun 2017 (actual)
Study completion: 1 Jun 2017 (actual)
First posted: 26 Sep 2016 (estimated)
Results: Posted 12 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Aim: To explore

the frequency of use of objective neuromuscular monitoring for assessment of depth of neuromuscular blockade in general anaesthesia
the incidence of residual neuromuscular blockade, and
the timing of reversal of the neuromuscular blockade at the end of anaesthesia.

We will collect data from 7 Danish anaesthesia departments, using data from the Anaesthesia Information Management System (AIMS).

Study design

Observational model: Other
Time perspective: Cross-sectional
Target follow-up: 1 Day
Number of arms: 1

Arm	Type	Receives
Eligible patients	–	Drug: Rocuronium, Drug: Succinylcholine, Drug: Cisatracurium, Drug: Mivacurium, Device: Objective neuromuscular monitoring (acceleromyography), Drug: Sugammadex, Drug: NeostigminePatients ≥15 years of age who received general anaesthesia with neuromuscular blockade in the last 18 months up until the time of data collection. Patients, who are eligible more than once, i.e. undergoing general anaesthesia on more than one occasion, will be included in the analyses as a case for every general anaesthetic received.

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients who received general anaesthesia with neuromuscular blockade

Key inclusion criteria (1 listed)

Patients who received general anaesthesia with neuromuscular blockade in one of the 7 hospitals providing data for the study in the last 18 months up until the time of data collection

Key exclusion criteria (0 listed)

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
Rocuronium	Drug	Eligible patients
Succinylcholine	Drug	Eligible patients
Cisatracurium	Drug	Eligible patients
Mivacurium	Drug	Eligible patients
Objective neuromuscular monitoring (acceleromyography)	Device	Eligible patients
Sugammadex	Drug	Eligible patients
Neostigmine	Drug	Eligible patients

Primary outcome

Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no)
Time frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no)
Time frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours

6 secondary outcomes

Last Recorded Train-of-four (TOF) Ratio Before Tracheal Extubation or Removal of Supraglottic Airway Device in Patients Receiving a Non-depolarizing NMBA
Time frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours
Number of Participants With and Without Administration of Sugammadex in Cases Receiving a Non-depolarizing NMBA (Yes/no)
Time frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Number of Participants With and Without Administration of Neostigmine in Cases Receiving a Non-depolarizing NMBA (Yes/no)
Time frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 5 hours
Time in Minutes From Tracheal Extubation or Removal of Supraglottic Airway Device to Discharge From Post-anaesthesia Care Unit in Cases Involving a Non-depolarizing NMBA With and Without Neuromuscular Monitoring, Respectively
Time frame: in the period from induction of anaesthesia to discharge from the post-anaesthesia care unit, usually 180 minutes
Number of Participants With and Without Mild Oxygen Desaturation (<90%, But >80%) in Cases Receiving a Non-depolarizing NMBA
Time frame: in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours
Number of Participants With and Without Severe Oxygen Desaturation (<80%) in Cases Receiving a Non-depolarizing NMBA
Time frame: in the period between tracheal extubation or removal of supraglottic airway device and discharge from post-anaesthesia care unit, assessed up to 24 hours

Results and safety

Results posted to the registry on 12 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Eligible Patients	30,430	30,430

Primary outcome: Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no)

Time frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours. Count of participants. Unit: Participants

Measure	Eligible Patients n = 16525
Monitoring applied	14463
Monitoring not applied	2062

Population analysed: Patients receiving non-depolarizing neuromuscular blocking agent

Primary outcome: Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Depolarizing NMBA (Succinylcholine) (Yes/no)

Time frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours. Count of participants. Unit: Participants

Measure	Eligible Patients n = 13905
Monitoring applied	4224
Monitoring not applied	9681

Population analysed: Patients receiving succinylcholine only

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Averse events data were not collected for the study because it was a retrospective database study. Adverse events were collected and reported by individual institutions according to local procedure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Eligible Patients	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Sharing of data not included in the permissions granted by authorities stated below

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
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RecruitingObservational study
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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.

Jakob L Thomsen, MD principal investigator

Sponsor principal investigator

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 Jakob Louis Thomsen at 1 site in Denmark.

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 1 inclusion and 0 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 12 Sep 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 Denmark. 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?

Yes. Results are posted in the registry (first posted 12 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With and Without Objective Neuromuscular Monitoring (Acceleromyography) in Cases Receiving a Non-depolarizing Neuromuscular Blocking Agent (NMBA) (Yes/no) (time frame: in the period from induction of anaesthesia to termination of anaesthesia, usually 2 hours). The study lists 2 primary outcomes in all. 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 NCT02914119.

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 12 Sep 2019.