Effect of Location of Tetanic Stimuli on Photoplethysmogram Under General Anesthesia
Primary Purpose
Stress Reaction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tetanic Stimulus
Sponsored by
About this trial
This is an interventional diagnostic trial for Stress Reaction focused on measuring photoplethysmography, stress response
Eligibility Criteria
Inclusion Criteria: Surgical patients Undergoing general anesthesia Able to consent in english 18 years of age or older Exclusion Criteria: Under 18 years of age unable to consent in english receiving regional anesthesia
Sites / Locations
- University of California San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tetanic Stimulus
Arm Description
all participants receive the same intervention
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05899686
First Posted
May 6, 2023
Last Updated
June 1, 2023
Sponsor
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT05899686
Brief Title
Effect of Location of Tetanic Stimuli on Photoplethysmogram Under General Anesthesia
Official Title
Effect of Tetanic Stimuli on Photoplethysmogram During General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 27, 2016 (Actual)
Primary Completion Date
May 12, 2016 (Actual)
Study Completion Date
May 12, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Reaction
Keywords
photoplethysmography, stress response
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tetanic Stimulus
Arm Type
Experimental
Arm Description
all participants receive the same intervention
Intervention Type
Device
Intervention Name(s)
Tetanic Stimulus
Intervention Description
5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order
Primary Outcome Measure Information:
Title
Tetanic stimulus induced change in photoplethysmography light transmission (in analog to digital units as measured using a pulse oximeter) from pre stimulus baseline
Description
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
Time Frame
Maximum light transmission change from pre tetanic stimulus baseline within 60 seconds after the tetanic stimulus
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Surgical patients
Undergoing general anesthesia
Able to consent in english
18 years of age or older
Exclusion Criteria:
Under 18 years of age
unable to consent in english
receiving regional anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pekka Talke, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94134
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Principal investigator will provide data for reasonable requests
Learn more about this trial
Effect of Location of Tetanic Stimuli on Photoplethysmogram Under General Anesthesia
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