Muscle RelaxationNCT03926650
The Correlation Between the Frontal Electromyography Parameter in Patient State Index (PSI) Monitor and Train of Four
An observational study of Muscle Relaxation, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial summary
The Train Of Four (TOF) Monitor will be placed on ulnar nerve on right wrist of the patients who has surgery under general anaesthesia. This is for stimulation of adductor pollicis muscle. Sedline (Masimo Electromyography(EMG) and Patient State Index(PSI)) Monitor will be placed on the frontal area of head. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Muscle Relaxation
- What is being tested?
- Masimo Sedline Monitor Patient State Index
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Aug 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients wha has surgery continues more then 1 hour
Who may be able to join
- surgery continues more then 1 hour
- between ages 18-65
- ASA I,II and III patients
Who cannot join
- The patients who has allergical reactions of the drugs used
- neurological or neuromuscular diseases
- the patients who use drugs effecting the neuromuscular junction
- pregnant patients
- electrolyte disregulations
- major organ failures, liver failure, kidney failure
- obese and cachectic patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Train Of Four (TOF) With Frontal EMG Parameter Measured by Patient State Index (PSI) Monitor in Extubation Phase of General Anesthesia
The Train Of Four (TOF) Monitor will be placed on ulnar nerve on right wrist of the patients who has surgery under general anaesthesia. This is for stimulation of adductor pollicis muscle. Sedline (Masimo Electromyography(EMG) and Patient State Index(PSI)) Monitor will be placed on the frontal area of head. After the induction of general anaesthesia the investigators will wait for disappearance of eyelash reflex. TOF monitor will be calibrated and muscle relaxant will be applied. After TOF is %0 and disappearance of thumb movement the patient will be intubated. After surgery the investigators will apply muscle relaxant reversal drugs. Then the investigators will record PSI and EMG parameters when TOF is %0, %25, %50,%75,%90. When TOF is %90 the investigators will extubate the patient. The investigators will record PSI and EMG parameters after 5 minutes.
Read the detailed description
The study is planned prospective and observational. The study started after approval of Erzincan Binali Yıldırım University Ethics Committee and taking written approval of patients. The study includes 84 patients who has surgery continues more then 1 hour, who is between ages 18-65, who is ASA I,II and III. The patients who has allergical reactions of the drugs used, neurological or neuromuscular diseases,the patients who use drugs effecting the neuromuscular junction, pregnant patients, electrolyte disregulations, major organ failures, liver failure, kidney failure, obese and cachectic patients are excluded from the study.
All patients will be informed and signed written approval 1 day before the surgery. Patients will be taken to the operating room, venous catheter will be applied on antecubital area. 3 channel EKG , SpO2 Monitor and noninvasive blood pressure monitorisation will be applied. The patients will be taken 2-4 litres of O2 with nasal cannula .The Train Of Four (TOF) Monitor will be placed on ulnar nerve on right wrist of the patients who has surgery under general anaesthesia. This is for stimulation of adductor pollicis muscle. Sedline (Masimo Electromyography(EMG) and Patient State Index(PSI)) Monitor will be placed on the frontal area of head. After the induction of general anaesthesia the investigators will wait for disappearance of eyelash reflex. TOF monitor will be calibrated and muscle relaxant will be applied. After TOF is %0 and disappearance of thumb movement the patient will be intubated. After surgery the investigators will apply muscle relaxant reversal drugs. PSI and EMG parameters will be recorded when TOF is %0, %25, %50,%75,%90. When TOF is %90 the investigators will extubate the patient. PSI and EMG parameters will be recorded after 5 minutes. The patient will be taken to the PACU room. On 5,10,30 minutes after surgery, the investigators will record aldrete score of patients.
- Conditions
- Muscle Relaxation
- Being tested
- Masimo Sedline Monitor Patient State Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo Sedline Monitor Patient State IndexDevice
Also called Train Of Four
Masimo Sedline Monitor shows frontal electromyography and patient state index, Train of four monitor shows muscle strength on adductor pollicis muscle
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient State Index
Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs
Measured: 0 minutes
Patient State Index
Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs
Measured: 1 minutes
Patient State Index
Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs
Measured: 2 minutes
Patient State Index
Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs
Measured: 3 minutes
Patient State Index
Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs
Measured: 4 minutes
Patient State Index
Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs
Measured: 5 minutes
Electromyography (Frontal EMG)
Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs
Measured: 0 minutes
Electromyography (Frontal EMG)
Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs
Measured: 1 minutes
Electromyography (Frontal EMG)
Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs
Measured: 2 minutes
Electromyography (Frontal EMG)
Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs
Measured: 3 minutes
Electromyography (Frontal EMG)
Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs
Measured: 4 minutes
Electromyography (Frontal EMG)
Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 Mar 2019
- Primary completion1 Mar 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RelaxationStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Gokalp TAS, Erzincan University
- Investigators
- Hakan G. Taş, Principal investigator, Mengucek Gazi Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926650
- Sponsor's protocol ID
- ErzincanUnv
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2019
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Train Of Four (TOF) With Frontal EMG Parameter Measured by Patient State Index (PSI) Monitor in Extubation Phase of General Anesthesia
- ClinicalTrials.gov ID
- NCT03926650
- Acronym / sponsor ID
- ErzincanUnv
- Conditions
- Muscle Relaxation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 24 Apr 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 Train Of Four (TOF) Monitor will be placed on ulnar nerve on right wrist of the patients who has surgery under general anaesthesia. This is for stimulation of adductor pollicis muscle. Sedline (Masimo Electromyography(EMG) and Patient State Index(PSI)) Monitor will be placed on the frontal area of head. After the induction of general anaesthesia the investigators will wait for disappearance of eyelash reflex. TOF monitor will be calibrated and muscle relaxant will be applied. After TOF is %0 and disappearance of thumb movement the patient will be intubated. After surgery the investigators will apply muscle relaxant reversal drugs. Then the investigators will record PSI and EMG parameters when TOF is %0, %25, %50,%75,%90. When TOF is %90 the investigators will extubate the patient. The investigators will record PSI and EMG parameters after 5 minutes.
Detailed description
The study is planned prospective and observational. The study started after approval of Erzincan Binali Yıldırım University Ethics Committee and taking written approval of patients. The study includes 84 patients who has surgery continues more then 1 hour, who is between ages 18-65, who is ASA I,II and III. The patients who has allergical reactions of the drugs used, neurological or neuromuscular diseases,the patients who use drugs effecting the neuromuscular junction, pregnant patients, electrolyte disregulations, major organ failures, liver failure, kidney failure, obese and cachectic patients are excluded from the study.
All patients will be informed and signed written approval 1 day before the surgery. Patients will be taken to the operating room, venous catheter will be applied on antecubital area. 3 channel EKG , SpO2 Monitor and noninvasive blood pressure monitorisation will be applied. The patients will be taken 2-4 litres of O2 with nasal cannula .The Train Of Four (TOF) Monitor will be placed on ulnar nerve on right wrist of the patients who has surgery under general anaesthesia. This is for stimulation of adductor pollicis muscle. Sedline (Masimo Electromyography(EMG) and Patient State Index(PSI)) Monitor will be placed on the frontal area of head. After the induction of general anaesthesia the investigators will wait for disappearance of eyelash reflex. TOF monitor will be calibrated and muscle relaxant will be applied. After TOF is %0 and disappearance of thumb movement the patient will be intubated. After surgery the investigators will apply muscle relaxant reversal drugs. PSI and EMG parameters will be recorded when TOF is %0, %25, %50,%75,%90. When TOF is %90 the investigators will extubate the patient. PSI and EMG parameters will be recorded after 5 minutes. The patient will be taken to the PACU room. On 5,10,30 minutes after surgery, the investigators will record aldrete score of patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients wha has surgery continues more then 1 hour
Key inclusion criteria (3 listed)
- surgery continues more then 1 hour
- between ages 18-65
- ASA I,II and III patients
Key exclusion criteria (7 listed)
- The patients who has allergical reactions of the drugs used
- neurological or neuromuscular diseases
- the patients who use drugs effecting the neuromuscular junction
- pregnant patients
- electrolyte disregulations
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 |
|---|---|---|
| Masimo Sedline Monitor Patient State IndexAlso: Train Of FourMasimo Sedline Monitor shows frontal electromyography and patient state index, Train of four monitor shows muscle strength on adductor pollicis muscle | Device | – |
Primary outcome
Patient State Index
Time frame: 0 minutes
Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs
Patient State Index
Time frame: 1 minutes
Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs
Patient State Index
Time frame: 2 minutes
Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs
Patient State Index
Time frame: 3 minutes
Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs
Patient State Index
Time frame: 4 minutes
Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs
Patient State Index
Time frame: 5 minutes
Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs
Electromyography (Frontal EMG)
Time frame: 0 minutes
Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs
Electromyography (Frontal EMG)
Time frame: 1 minutes
Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs
Electromyography (Frontal EMG)
Time frame: 2 minutes
Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs
Electromyography (Frontal EMG)
Time frame: 3 minutes
Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs
Electromyography (Frontal EMG)
Time frame: 4 minutes
Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs
Electromyography (Frontal EMG)
Time frame: 5 minutes
Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs
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 9 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Hakan G. Taş principal investigator
Mengucek Gazi Education and Research Hospital
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 Muscle Relaxation, run by Erzincan University at 1 site in Turkey (Türkiye).
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 7 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 9 Apr 2021. 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 Turkey (Türkiye). 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?
Patient State Index (time frame: 0 minutes). The study lists 12 primary outcomes in all. 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 9 Apr 2021.