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The effect of the location of tetanic stimulus on photoplethysmography signals will be studied in patients under general anesthesia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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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 anatomical locations in each subject. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Maximum light transmission change from pre tetanic stimulus baseline within 60 seconds after the tetanic stimulus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pekka Talke, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94134 | United States |
Principal investigator will provide data for reasonable requests
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Stimuli were administered to three locations: A, B and C. Thus, there were 6 possible location sequences. ABC, ACB, BAC, BCA, CAB and CBA. These six location sequences were randomized in blocks of six (one of each) o that the sequence itself would not generate a bias. Thus, with 12 participants, each location sequence had two participants enrolled. For analysis the data for each location was pooled, independent of the location sequence.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tetanic Stimulus | all participants receive the same intervention Tetanic Stimulus: 5 second 100 Hz 70 mA tetanic stimulus will be applied to each subject at three different anatomical locations. The order of the three locations will be randomized. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tetanic Stimulus | all participants receive the same intervention Tetanic Stimulus: 5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order |
| 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, Categorical | Count of Participants |
| 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 | 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 | Posted | Mean | Standard Deviation | percentage change from baseline value | Maximum light transmission change from pre tetanic stimulus baseline within 60 seconds after the tetanic stimulus |
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Principal investigator interviewed all subjects regarding adverse events after patients recovered from anesthesia, the day of the study.
Principal investigator interviewed all subjects regarding adverse events after the surgical procedure and anesthesia.
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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 | Tetanic Stimulus | all participants receive the same intervention Tetanic Stimulus: 5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pekka Talke | UCaliforniaSF | 4153063602 | pekka.talke@ucsf.edu |
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| ID | Term |
|---|---|
| D015775 | Fractures, Stress |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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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.
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
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