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The effect of the location of tetanic stimulus on photoplethysmography signals will be studies in patients under general anesthesia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention | Experimental | all participants receive the same intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetanic Stimulus | Device | 5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1-2 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94122 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38223663 | Derived | 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. |
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12 surgical patients were recruited between 10/3/19/2018 and 11/30/2018. All subjects completed the study. Study was conducted in surgical patients under general anesthesia at UCSF
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | All subjects received the same intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | All subjects received the same intervention |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | arbitrary units | 1-2 minutes |
|
From beginning of general anesthesia till end of study data collection during general anesthesia which was approximately one hour.
Tetanic stimulus (the only intervention of this study) has never been associated with adverse events. Tetanic stimulus is routinely used during general anesthesia to assess neuromusculer blockade.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | All subjects received the same intervention. There were no adverse effects |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pekka Talke | UCalifornia San Francisco | 415 306 3602 | pekka.talke@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2020 | Apr 18, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| photoplethysmagraph AC/DC values 60 seconds before each tetanic stimulus was considered as the basee | photoplethysmographs (PPG) record transmitted infrared light through the finger. The PPG signal is recorded in arbitrary units (from A to D converter). The varying part of the signal (due to cardiac contractions) is called AC. The values from zero to the bottom of the varying part is called DC. In the study I used AC/DC*100. This ratio approximates the portion of the signal (in percent) that varies over time. A lower AC/DC is normally recorded when blood vessels are vasoconstricted. The baseline AC/DC in this study refers to the values immediately before intervention. | Mean | Standard Deviation | arbitrary units |
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| Units | Counts |
|---|---|
| Participants |
|
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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