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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03648853
Other study ID # PT1801
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date November 30, 2018

Study information

Verified date May 2020
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The effect of the location of tetanic stimulus on photoplethysmography signals will be studies in patients under general anesthesia.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Surgical patients general anesthesia able to consent in english

Exclusion Criteria:

- regional anesthesia unable to consent in english under 18 yrs of age

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Tetanic Stimulus
5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order

Locations

Country Name City State
United States University of California San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. 1-2 minutes
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