Neuromuscular BlockadeNCT05992090
Neuromuscular Blockade Monitoring Using Kine-myography vs Electromyography.
An observational study of Neuromuscular Blockade and Residual Neuromuscular Blockade, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
Trial summary
This study aims to compare two monitoring methods of neuromuscular blockade - Kine-myography and Electromyography. The main questions to answer are: are electromyography and kine-myography interchangeable is electromyography linked to fewer fault results is electromyography using lower energy to stimulate nerves The… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neuromuscular Blockade, Residual Neuromuscular Blockade
- How many people
- 129 participants
- Where
- 1 siteCzechia
- Study dates
- 10 Oct 2023to 29 May 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will be selected from residents of the Northern Bohemia region. All included patients will be indicated for surgery in general anesthesia with the need for neuromuscular blockade. All selected patients will be hospitalized at Masaryk Hospital in Ústí nad Labem.
Who may be able to join
- patients undergoing surgery under general anaesthesia with the use of cis-atracurium or rocuronium
Who cannot join
- patients suffering from neuromuscular diseases
- patients with known allergy to rocuronium or cis-atracurium
- patients in whom it is impossible to measure the depth of the neuromuscular block on the upper extremities (injuries of the upper extremities, contractures etc.)
- patients undergoing surgery positioned on their side
- patients with an upper arm injury
- patients with acromegaly
Show all 10Show fewer
- patients with Alzheimer's disease
- patients with the risk of difficult airways
- patients induced into general anaesthesia via the Rapid Sequence Induction method
- patients with a weight under 5 kilograms
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Masarykova Nemocnice v Ústí nad Labem, Krajská Zdravotní a.s.
Ústí nad Labem, Ústí nad Labem Region, 40001
About this study
Official title: Neuromuscular Blockade Monitoring Using Kine-myography vs Electromyography in Patients Undergoing General Anaesthesia With the Use of Rocuronium and Cis-atracurium.
This study aims to compare two monitoring methods of neuromuscular blockade - Kine-myography and Electromyography.
The main questions to answer are:
- are electromyography and kine-myography interchangeable
- is electromyography linked to fewer fault results
- is electromyography using lower energy to stimulate nerves
The type of study is a multicentric observational clinical trial. Subjects are patients undergoing general anaesthesia with the use of rocuronium or cis-atracurium. In each patient, the neuromuscular blockade will be monitored using kine-myograph and electromyography simultaneously.
Read the detailed description
Informed consent will first be obtained from the patient for inclusion in the study. Consent will be obtained during an examination by the anaesthesiologist providing anaesthetic care during surgery in the anteroom of the operating theatre.
Once informed consent has been obtained, a routine orientation examination will be performed by the anaesthetist and routine pre-operative preparation (provision of peripheral venous access, risk assessment for airway obstruction, etc.) will be performed. The patient will then be transported to the operating theatre.
In the operating room, patient monitoring will be initiated, including the deployment of sensors to monitor the depth of neuromuscular blockade. The KMG sensor will be placed on the right arm and the EMG sensor on the left arm. After deployment of the sensors, upper limb fixation will be performed by the anaesthetic nurse. The fixation will be performed with splints compatible with the operating table. Fixation of the limbs and sensor with adhesive tape will not be used.
The anaesthesia will then be induced. Propofol and sufentanil will be administered at the discretion of the anaesthetist providing anaesthetic care. Once sufficient depth of sedation has been induced, calibration of the sensors monitoring the depth of neuromuscular blockade will be performed. After calibration of the sensors, the supramaximal current to the CRF will be recorded. The measurement interval will be set to 20 s. After securing the airway, the interval will be extended to 5 - 15 min according to the nature of the surgery and the discretion of the anaesthesiologist providing anaesthetic care. The number of twitches (PCT) and the Train Of Four (TOF) value will be recorded throughout the procedure.
On emergence from anaesthesia, the measurement interval will be set to 1 minute. Once sufficient depth of neuromuscular blockade has been reached to allow extubation, monitoring of the depth of neuromuscular blockade will be discontinued.
If during the measurement of the depth of neuromuscular blockade a value is measured that is highly suspected to be in error, this suspicion will be recorded in the CRF with a justification.
- Keywords
- neuromuscular blockade, electromyography, kine-myography, general anaesthesia, rocuronium, cis-atracurium, residual neuromuscular blockade, sugammadex
- Medical subject headings
- Delayed Emergence from Anesthesia
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement variability
A primary aim is to demonstrate that measurement of the depth of neuromuscular blockade using kinemyography is associated with a higher measurement variability than measurement of the depth of neuromuscular blockade using electromyography.
Measured: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
Secondary outcomes (2)
supramaximal electric stimulus
A secondary aim is to demonstrate that measuring the depth of neuromuscular blockade using kinemyography is associated with a higher supramaximal electric stimulus than measuring the depth of neuromuscular blockade using electromyography.
Measured: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
TOF overestimation
The primary objective of the study is to demonstrate that there is measured higher TOF when using KMG to monitor the depth of neuromuscular blockade compared to using EMG sensor to monitor the depth of neuromuscular blockade.
Measured: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start10 Oct 2023
- Primary completion29 May 2024
- Study completion29 May 2024
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.
- 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Kalina, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Investigators
- Michal Kalina, MUDr., Principal investigator, Krajská Zdravotní a.s., Masarykova Nemocnice v Ústí nad Labem, Klinika anesteziologie, perioperační a intenzivní medicíny FZS UJEP a MNUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992090
- Sponsor's protocol ID
- EMG vs KMG
- Status last verified
- Jul 2024
- First submitted
- 7 Aug 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Blockade Monitoring Using Kine-myography vs Electromyography in Patients Undergoing General Anaesthesia With the Use of Rocuronium and Cis-atracurium.
- ClinicalTrials.gov ID
- NCT05992090
- Acronym / sponsor ID
- EMG vs KMG
- Keywords
- neuromuscular blockade, electromyography, kine-myography, general anaesthesia, rocuronium, cis-atracurium, residual neuromuscular blockade, sugammadex
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.University, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 15 Aug 2023 (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.
This study aims to compare two monitoring methods of neuromuscular blockade - Kine-myography and Electromyography.
The main questions to answer are:
- are electromyography and kine-myography interchangeable
- is electromyography linked to fewer fault results
- is electromyography using lower energy to stimulate nerves
The type of study is a multicentric observational clinical trial. Subjects are patients undergoing general anaesthesia with the use of rocuronium or cis-atracurium. In each patient, the neuromuscular blockade will be monitored using kine-myograph and electromyography simultaneously.
Detailed description
Informed consent will first be obtained from the patient for inclusion in the study. Consent will be obtained during an examination by the anaesthesiologist providing anaesthetic care during surgery in the anteroom of the operating theatre.
Once informed consent has been obtained, a routine orientation examination will be performed by the anaesthetist and routine pre-operative preparation (provision of peripheral venous access, risk assessment for airway obstruction, etc.) will be performed. The patient will then be transported to the operating theatre.
In the operating room, patient monitoring will be initiated, including the deployment of sensors to monitor the depth of neuromuscular blockade. The KMG sensor will be placed on the right arm and the EMG sensor on the left arm. After deployment of the sensors, upper limb fixation will be performed by the anaesthetic nurse. The fixation will be performed with splints compatible with the operating table. Fixation of the limbs and sensor with adhesive tape will not be used.
The anaesthesia will then be induced. Propofol and sufentanil will be administered at the discretion of the anaesthetist providing anaesthetic care. Once sufficient depth of sedation has been induced, calibration of the sensors monitoring the depth of neuromuscular blockade will be performed. After calibration of the sensors, the supramaximal current to the CRF will be recorded. The measurement interval will be set to 20 s. After securing the airway, the interval will be extended to 5 - 15 min according to the nature of the surgery and the discretion of the anaesthesiologist providing anaesthetic care. The number of twitches (PCT) and the Train Of Four (TOF) value will be recorded throughout the procedure.
On emergence from anaesthesia, the measurement interval will be set to 1 minute. Once sufficient depth of neuromuscular blockade has been reached to allow extubation, monitoring of the depth of neuromuscular blockade will be discontinued.
If during the measurement of the depth of neuromuscular blockade a value is measured that is highly suspected to be in error, this suspicion will be recorded in the CRF with a justification.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be selected from residents of the Northern Bohemia region. All included patients will be indicated for surgery in general anesthesia with the need for neuromuscular blockade. All selected patients will be hospitalized at Masaryk Hospital in Ústí nad Labem.
Key inclusion criteria (1 listed)
- patients undergoing surgery under general anaesthesia with the use of cis-atracurium or rocuronium
Key exclusion criteria (10 listed)
- patients suffering from neuromuscular diseases
- patients with known allergy to rocuronium or cis-atracurium
- patients in whom it is impossible to measure the depth of the neuromuscular block on the upper extremities (injuries of the upper extremities, contractures etc.)
- patients undergoing surgery positioned on their side
- patients with an upper arm injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement variability
Time frame: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
A primary aim is to demonstrate that measurement of the depth of neuromuscular blockade using kinemyography is associated with a higher measurement variability than measurement of the depth of neuromuscular blockade using electromyography.
2 secondary outcomes
supramaximal electric stimulus
Time frame: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
TOF overestimation
Time frame: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
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 12 Jul 2024.
- Individual participant dataSharing planned: Undecided
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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.
Michal Kalina, MUDr. principal investigator
Krajská Zdravotní a.s., Masarykova Nemocnice v Ústí nad Labem, Klinika anesteziologie, perioperační a intenzivní medicíny FZS UJEP a MNUL
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 and Residual Neuromuscular Blockade, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
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 10 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 Jul 2024. 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 Czechia. 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?
Measurement variability (time frame: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.). 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 12 Jul 2024.