Effect of Location of Tetanic Stimuli on Photoplethysmogram Under General Anesthesia

May 8, 2024 updated by: University of California, San Francisco

Effect of Tetanic Stimuli on Photoplethysmogram During General Anesthesia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94134
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tetanic Stimulus
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.
Device: Tetanic Stimulus
5 second 100 Hz 70 mA tetanic stimulus will be applied to three different anatomical locations in each subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Maximum light transmission change from pre tetanic stimulus baseline within 60 seconds after the tetanic stimulus
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Pekka Talke, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2016

Primary Completion (Actual)

May 12, 2016

Study Completion (Actual)

May 12, 2016

Study Registration Dates

First Submitted

May 6, 2023

First Submitted That Met QC Criteria

June 1, 2023

First Posted (Actual)

June 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT1502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Principal investigator will provide data for reasonable requests

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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