Stress ReactionNCT03648853
Effect of Location of Tetanic Stimuli on Photoplethysmogram
A study testing Tetanic Stimulus in people with Stress Reaction, run by University of California, San Francisco at 1 site in United States.
Trial summary
The effect of the location of tetanic stimulus on photoplethysmography signals will be studies in patients under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Reaction
- What is being tested?
- Tetanic Stimulus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 30 Nov 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical patients general anesthesia able to consent in english
Who cannot join
- regional anesthesia unable to consent in english under 18 yrs of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94122
About this study
Official title: Effect of Location of Tetanic Stimuli on Photopethysmogram During General Anesthesia
The effect of the location of tetanic stimulus on photoplethysmography signals will be studies in patients under general anesthesia.
Read the detailed description
A 5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order in patients who are under general anesthesia. Tetanic stimuli are used routinely during general anesthesia to assess effectiveness of neuromuscular blockade. These tetanic stimuli are noxious stimuli that elicit a stress response which can be quantified using photoplethysmography. This study investigates if the magnitude of the tetanus induced stress response is dependent on the location of the tetanic stimulus as measured by photoplythysmography.
- Conditions
- Stress Reaction
- Being tested
- Tetanic Stimulus
- Keywords
- photoplethysmography, stress response
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanic StimulusDevice
5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | all participants receive the same intervention Receives: Device: Tetanic Stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photoplethysmography (PPG)
Change in the PPG signal in response to tetanic stimulus. A tetanic stimulus will cause vasoconstriction which can be recorded as a decrease in PPG AC/DC. The outcome measure is the maximum decrease in AC/DC from baseline. Maximum decrease happens typically in 30-60 seconds after the stimulus. Thus, data was collected immediately before (baseline) and for 2 min after the stimulus. After the stimulus AC/DC values return to baseline in a few minutes. Baseline AC/DC measures a relative state of blood vessel tone. In anesthetized patients the AC/DC values can range from close to 0 to above 10. The higher the value, the more vasodilated the subject is.
Measured: 1-2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start1 Sep 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress ReactionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pekka Talke, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648853
- Sponsor's protocol ID
- PT1801
- Status last verified
- May 2020
- First submitted
- 24 Aug 2018
- Last updated
- 22 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Talke P, Talke I. Effect of the Location of Tetanic Stimulation on Autonomic Responses: A Randomized Cross-Over Pilot Study. J Pain Res. 2024 Jan 9;17:209-217. doi: 10.2147/JPR.S443058. eCollection 2024.
PubMed 38223663
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Location of Tetanic Stimuli on Photopethysmogram During General Anesthesia
- ClinicalTrials.gov ID
- NCT03648853
- Acronym / sponsor ID
- PT1801
- Conditions
- Stress Reaction
- Keywords
- photoplethysmography, stress response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 27 Aug 2018 (actual)
- Results
- Posted 30 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of the location of tetanic stimulus on photoplethysmography signals will be studies in patients under general anesthesia.
Detailed description
A 5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order in patients who are under general anesthesia. Tetanic stimuli are used routinely during general anesthesia to assess effectiveness of neuromuscular blockade. These tetanic stimuli are noxious stimuli that elicit a stress response which can be quantified using photoplethysmography. This study investigates if the magnitude of the tetanus induced stress response is dependent on the location of the tetanic stimulus as measured by photoplythysmography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: Tetanic Stimulusall participants receive the same intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Surgical patients general anesthesia able to consent in english
Key exclusion criteria (1 listed)
- regional anesthesia unable to consent in english under 18 yrs of age
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 |
|---|---|---|
| Tetanic Stimulus5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order | Device | intervention |
Primary outcome
Photoplethysmography (PPG)
Time frame: 1-2 minutes
Change in the PPG signal in response to tetanic stimulus. A tetanic stimulus will cause vasoconstriction which can be recorded as a decrease in PPG AC/DC. The outcome measure is the maximum decrease in AC/DC from baseline. Maximum decrease happens typically in 30-60 seconds after the stimulus. Thus, data was collected immediately before (baseline) and for 2 min after the stimulus. After the stimulus AC/DC values return to baseline in a few minutes. Baseline AC/DC measures a relative state of blood vessel tone. In anesthetized patients the AC/DC values can range from close to 0 to above 10. The higher the value, the more vasodilated the subject is.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38223663Talke P, Talke I. Effect of the Location of Tetanic Stimulation on Autonomic Responses: A Randomized Cross-Over Pilot Study. J Pain Res. 2024 Jan 9;17:209-217. doi: 10.2147/JPR.S443058. eCollection 2024.
- 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.
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?
A study testing Tetanic Stimulus in people with Stress Reaction, run by University of California, San Francisco at 1 site in United States.
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 1 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 22 May 2020. 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 United States. 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 30 Apr 2020). 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?
Photoplethysmography (PPG) (time frame: 1-2 minutes). 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 NCT03648853, which also lists 1 linked publication.
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 22 May 2020.