RelaxationNCT06711796
Measurement of Muscle Relaxation of the Hand in From Two Muscles and Two Hand Positions
An observational study of Relaxation, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Does movement of hand from supination to pronation affect the cut threshold for electomyography (EMG) relaxation measurement Does the threshold level differ between adductor pollucis and dorsal interosseus muscle Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Relaxation
- What is being tested?
- emg measurement in adductor pollucis
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteFinland
- Study dates
- 1 Oct 2024to 17 Jan 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing elective surgery with estimated time over 45 minutes and no need for muscle relaxation
Who may be able to join
- age 18-65 years
- American society of anesthesiology (ASA) classification 1-2
- Elective surgery under general anesteshia with no planned need for muscle relaxation
- Body mass index <35 kg/m3
Who cannot join
- Know central nervous system disease
- Know central nervous system impairment
- known medication affection peripheral nervous system
Trial locations and contacts
1 site in 1 country.
About this study
Does movement of hand from supination to pronation affect the cut threshold for electomyography (EMG) relaxation measurement Does the threshold level differ between adductor pollucis and dorsal interosseus muscle
- Conditions
- Relaxation
- Being tested
- emg measurement in adductor pollucis
- Keywords
- Train of four, EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emg measurement in adductor pollucisDevice
EMG measurement from adductor pollucis and dorsal interosseus muscles in supination and pronation using increasing stimulation current
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | Patients undergiong surgery with no need for muscle relaxation Receives: Device: emg measurement in adductor pollucis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To differ the difference in the stimulation current between adductor pollucis and dorsal interosseus muscles
Defining the supramaximal stimulation current in the hand using EMG muscle rekaxation
Measured: 30 minutes
To differ the stimulation threshold in hand supination and pronation postures
Measuring the EMG stimulation threshold in two hand postures
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Oct 2024
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RelaxationStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711796
- Sponsor's protocol ID
- R23091L
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Physionet registry - pseudonymised measurement data
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Muscle Relaxation of the Hand in From Two Muscles and Two Hand Positions
- ClinicalTrials.gov ID
- NCT06711796
- Acronym / sponsor ID
- R23091L
- Conditions
- Relaxation
- Keywords
- Train of four, EMG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 2 Dec 2024 (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.
Does movement of hand from supination to pronation affect the cut threshold for electomyography (EMG) relaxation measurement Does the threshold level differ between adductor pollucis and dorsal interosseus muscle
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Device: emg measurement in adductor pollucisPatients undergiong surgery with no need for muscle relaxation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery with estimated time over 45 minutes and no need for muscle relaxation
Key inclusion criteria (4 listed)
- age 18-65 years
- American society of anesthesiology (ASA) classification 1-2
- Elective surgery under general anesteshia with no planned need for muscle relaxation
- Body mass index <35 kg/m3
Key exclusion criteria (3 listed)
- Know central nervous system disease
- Know central nervous system impairment
- known medication affection peripheral nervous system
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 |
|---|---|---|
| emg measurement in adductor pollucisEMG measurement from adductor pollucis and dorsal interosseus muscles in supination and pronation using increasing stimulation current | Device | Study cohort |
Primary outcome
To differ the difference in the stimulation current between adductor pollucis and dorsal interosseus muscles
Time frame: 30 minutes
Defining the supramaximal stimulation current in the hand using EMG muscle rekaxation
To differ the stimulation threshold in hand supination and pronation postures
Time frame: 30 minutes
Measuring the EMG stimulation threshold in two hand postures
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 6 Feb 2025.
- Individual participant dataSharing planned: Yes. Physionet registry - pseudonymised measurement data
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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.
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 Relaxation, run by Tampere University Hospital at 1 site in Finland.
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 4 inclusion and 3 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 6 Feb 2025. 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 Finland. 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?
To differ the difference in the stimulation current between adductor pollucis and dorsal interosseus muscles (time frame: 30 minutes). 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?
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 6 Feb 2025.