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Effect of Location of Tetanic Stimuli on Photoplethysmogram

Effect of Location of Tetanic Stimuli on Photopethysmogram During General Anesthesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03648853
Enrollment
12
Registered
2018-08-27
Start date
2018-09-01
Completion date
2018-11-30
Last updated
2020-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Reaction

Keywords

photoplethysmography, stress response

Brief summary

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.

Interventions

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

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Photoplethysmography (PPG)1-2 minutesChange 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.

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
Intervention
All subjects received the same intervention
12
Total12

Baseline characteristics

CharacteristicIntervention
Age, Continuous49 years
STANDARD_DEVIATION 18
photoplethysmagraph AC/DC values 60 seconds before each tetanic stimulus was considered as the basee5.4 arbitrary units
STANDARD_DEVIATION 1.95
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
12 Participants
Sex: Female, Male
Female
8 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 12
other
Total, other adverse events
0 / 12
serious
Total, serious adverse events
0 / 12

Outcome results

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.

Time frame: 1-2 minutes

ArmMeasureValue (MEAN)Dispersion
InterventionPhotoplethysmography (PPG)3.3 arbitrary unitsStandard Deviation 1.6

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026