Transcutaneous Electrical Nerve StimulationNCT05046054
The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Propofol Injection
A study testing transcutaneous electrical nerve stimulation in people with Transcutaneous Electrical Nerve Stimulation and Pain, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
Propofol, an intravenous sedative agent, frequently produces pain during injection. This study was designed to investigate whether transcutaneous electrical nerve stimulation could reduce pain during propofol injection. in minimizing propofol injection pain. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Transcutaneous Electrical Nerve Stimulation, Pain, Propofol Adverse Reaction
- What is being tested?
- transcutaneous electrical nerve stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2021to 30 Jan 2022
- Phase
- Interventional
- 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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- American Society of Anesthesiologists physical status classification > 3
- Patient with a history of allergy to drugs
- Patient who takes opioid, sedative, anticonvulsant
- Patient with a history of neurologic disease and psychological disorders
- patient with skin problem
- Patient with pacemaker or electric medical device
- pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook National university hospital
Daegu, 41944
Younghoon Jeon, +82534205863, jeon68@gmail.com
About this study
Propofol, an intravenous sedative agent, frequently produces pain during injection. This study was designed to investigate whether transcutaneous electrical nerve stimulation could reduce pain during propofol injection.
in minimizing propofol injection pain.
Read the detailed description
Twenty min after transcutaneous electrical nerve stimulation, the electrodes were removed and propofol 0.5 mg/kg was administered at the rate of 0.5 ml/sec using syringe pump. Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale: 0=no (negative response to questioning), 1=mild pain (pain reported only in response to questioning without any behavioral sings), 2=moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontaneously without questioning, 3=severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears).
- Being tested
- transcutaneous electrical nerve stimulation, Placebo transcutaneous electrical nerve stimulation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical nerve stimulationDevice
transcutaneous electrical nerve stimulation group received transcutaneous electrical nerve stimulation via two electrodes on the venous cannulation site 20 min before propofol injection
Placebo transcutaneous electrical nerve stimulationDevice
Placebo transcutaneous electrical nerve stimulation group received no transcutaneous electrical nerve stimulation via two electrodes on the venous cannulation site 20 min before propofol injection
| Study group | Role | What they receive |
|---|---|---|
| transcutaneous electrical nerve stimulation group | Active comparator | Transcutaneous electrical nerve stimulation was givent via two electrodes on the venous cannulation site 20 min before propofol injection Receives: Device: transcutaneous electrical nerve stimulation |
| control group | Placebo comparator | No transcutaneous electrical nerve stimulation was not given via two electrodes on the venous cannulation site 20 min before propofol injection Receives: Device: Placebo transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during propofol injection
Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale
Measured: 15 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Jun 2021
- Primary completion30 Jan 2022 (estimated)
- Study completion30 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcutaneous Electrical Nerve StimulationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TENS YW-5000 (YoungWon Medical Co, Korea)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younghoon Jeon, Kyungpook National University Hospital
- Investigators
- Younghoon Jeon, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046054
- Sponsor's protocol ID
- 2021-03-036-001
- Status last verified
- Jan 2022
- First submitted
- 5 Sep 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Nerve Stimulation on Pain During Propofol Injection
- ClinicalTrials.gov ID
- NCT05046054
- Acronym / sponsor ID
- 2021-03-036-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 30 Jan 2022 (estimated)
- First posted
- 16 Sep 2021 (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.
Propofol, an intravenous sedative agent, frequently produces pain during injection. This study was designed to investigate whether transcutaneous electrical nerve stimulation could reduce pain during propofol injection.
in minimizing propofol injection pain.
Detailed description
Twenty min after transcutaneous electrical nerve stimulation, the electrodes were removed and propofol 0.5 mg/kg was administered at the rate of 0.5 ml/sec using syringe pump. Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale: 0=no (negative response to questioning), 1=mild pain (pain reported only in response to questioning without any behavioral sings), 2=moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontaneously without questioning, 3=severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- TENS YW-5000 (YoungWon Medical Co, Korea)
| Arm | Type | Receives |
|---|---|---|
| transcutaneous electrical nerve stimulation group | Active comparator | Device: transcutaneous electrical nerve stimulationTranscutaneous electrical nerve stimulation was givent via two electrodes on the venous cannulation site 20 min before propofol injection |
| control group | Placebo comparator | Device: Placebo transcutaneous electrical nerve stimulationNo transcutaneous electrical nerve stimulation was not given via two electrodes on the venous cannulation site 20 min before propofol injection |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (7 listed)
- American Society of Anesthesiologists physical status classification > 3
- Patient with a history of allergy to drugs
- Patient who takes opioid, sedative, anticonvulsant
- Patient with a history of neurologic disease and psychological disorders
- patient with skin problem
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 |
|---|---|---|
| transcutaneous electrical nerve stimulationtranscutaneous electrical nerve stimulation group received transcutaneous electrical nerve stimulation via two electrodes on the venous cannulation site 20 min before propofol injection | Device | transcutaneous electrical nerve stimulation group |
| Placebo transcutaneous electrical nerve stimulationPlacebo transcutaneous electrical nerve stimulation group received no transcutaneous electrical nerve stimulation via two electrodes on the venous cannulation site 20 min before propofol injection | Device | control group |
Primary outcome
pain during propofol injection
Time frame: 15 seconds
Propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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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.
Younghoon Jeon principal investigator
Kyungpook National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical nerve stimulation in people with Transcutaneous Electrical Nerve Stimulation and Pain, run by Kyungpook National University Hospital at 1 site in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 19 Jan 2022. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Younghoon Jeon, Dr (+82534205863, jeon68@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain during propofol injection (time frame: 15 seconds). 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 19 Jan 2022.