Stress ReactionNCT05899686
Effect of Location of Tetanic Stimuli on Photoplethysmogram Under General Anesthesia
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 studied in patients under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- 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
- 27 Jan 2016to 12 May 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Surgical patients
- Undergoing general anesthesia
- Able to consent in english
- 18 years of age or older
Who cannot join
- Under 18 years of age
- unable to consent in english
- receiving regional anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94134
About this study
Official title: Effect of Tetanic Stimuli on Photoplethysmogram During General Anesthesia
The effect of the location of tetanic stimulus on photoplethysmography signals will be studied 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 (Ulnar nerve, Facial nerve, Posterior Tibial nerve) 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 photoplethysmography.
- 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 anatomical locations in each subject.
| Study group | Role | What they receive |
|---|---|---|
| Tetanic Stimulus | Experimental | all participants receive the same intervention, which is three tetanic stimuli applied to three different anatomical locations. The three anatomical locations are identical in all subjects. Receives: Device: Tetanic Stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tetanic Stimulus Induced Change in Photoplethysmography Light Transmission (in Analog to Digital Units as Measured Using a Pulse Oximeter) From Pre Stimulus Baseline
Tetanic stimulation will induce peripheral vasoconstriction. This will be measured using photoplethysmography. During peripheral vasoconstriction the light transmission through finger will increase. The primary outcome will be the maximum change in light transmission (as measured by photoplethysmography) within 60 seconds after a tetanic stimulus as compared to pre stimulus baseline values. These maximal light transmission changes will be compared between the three different tetanic stimulus sites
Measured: Maximum light transmission change from pre tetanic stimulus baseline within 60 seconds after the tetanic stimulus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start27 Jan 2016
- Primary completion12 May 2016
- Study completion12 May 2016
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.
- 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
- Model description
- Each participant will receive three tetanic stimuli. They are applied to the same three anatomical locations in each subject, but the order at which they are delivered to these locations will be random.
- 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
- Sponsor
- Investigators
- Pekka Talke, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899686
- Sponsor's protocol ID
- PT1502
- Status last verified
- May 2024
- First submitted
- 6 May 2023
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Principal investigator will provide data for reasonable requests
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tetanic Stimuli on Photoplethysmogram During General Anesthesia
- ClinicalTrials.gov ID
- NCT05899686
- Acronym / sponsor ID
- PT1502
- 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
- 27 Jan 2016 (actual)
- Primary completion
- 12 May 2016 (actual)
- Study completion
- 12 May 2016 (actual)
- First posted
- 12 Jun 2023 (actual)
- Results
- Posted 16 May 2024
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 studied in patients under general anesthesia.
Detailed description
A 5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations (Ulnar nerve, Facial nerve, Posterior Tibial nerve) 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 photoplethysmography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each participant will receive three tetanic stimuli. They are applied to the same three anatomical locations in each subject, but the order at which they are delivered to these locations will be random.
| Arm | Type | Receives |
|---|---|---|
| Tetanic Stimulus | Experimental | Device: Tetanic Stimulusall participants receive the same intervention, which is three tetanic stimuli applied to three different anatomical locations. The three anatomical locations are identical in all subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Surgical patients
- Undergoing general anesthesia
- Able to consent in english
- 18 years of age or older
Key exclusion criteria (3 listed)
- Under 18 years of age
- unable to consent in english
- receiving regional anesthesia
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 anatomical locations in each subject. | Device | Tetanic Stimulus |
Primary outcome
Tetanic Stimulus Induced Change in Photoplethysmography Light Transmission (in Analog to Digital Units as Measured Using a Pulse Oximeter) From Pre Stimulus Baseline
Time frame: Maximum light transmission change from pre tetanic stimulus baseline within 60 seconds after the tetanic stimulus
Tetanic stimulation will induce peripheral vasoconstriction. This will be measured using photoplethysmography. During peripheral vasoconstriction the light transmission through finger will increase. The primary outcome will be the maximum change in light transmission (as measured by photoplethysmography) within 60 seconds after a tetanic stimulus as compared to pre stimulus baseline values. These maximal light transmission changes will be compared between the three different tetanic stimulus sites
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Principal investigator will provide data for reasonable requests
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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.
Pekka Talke, MD principal investigator
University of California, San Francisco
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 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 16 May 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 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 16 May 2024). 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?
Tetanic Stimulus Induced Change in Photoplethysmography Light Transmission (in Analog to Digital Units as Measured Using a Pulse Oximeter) From Pre Stimulus Baseline (time frame: Maximum light transmission change from pre tetanic stimulus baseline within 60 seconds after the tetanic stimulus). 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 16 May 2024.