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Effect of Location of Tetanic Stimuli on Photoplethysmogram

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648853
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Pekka Talke, University of California, San Francisco

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

Condition or disease Intervention/treatment Phase
Stress Reaction Device: Tetanic Stimulus Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Effect of Location of Tetanic Stimuli on Photopethysmogram During General Anesthesia
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

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


Primary Outcome Measures :
  1. Photoplethysmography (PPG) [ Time Frame: 1-2 minutes ]
    Change in the PPG signal in response to tetanic stimulus



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648853


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94122
Sponsors and Collaborators
University of California, San Francisco

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Responsible Party: Pekka Talke, MD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03648853    
Other Study ID Numbers: PT1801
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Pekka Talke, University of California, San Francisco:
photoplethysmography
stress response
Additional relevant MeSH terms:
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Fractures, Stress
Fractures, Bone
Wounds and Injuries