Effect of Location of Tetanic Stimuli on Photoplethysmogram Under General Anesthesia

NCT05899686 | Completed Results FDA Device

• 1 other identifier: PT1502
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress Reaction

Keywords

photoplethysmography; stress response

Outcome Measures

Primary Outcomes (1)

• 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

  Maximum light transmission change from pre tetanic stimulus baseline within 60 seconds after the tetanic stimulus

Study Arms (1)

Tetanic Stimulus

EXPERIMENTAL

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

Interventions

Tetanic Stimulus DEVICE

5 second 100 Hz 70 mA tetanic stimulus will be applied to three different anatomical locations in each subject.

Tetanic Stimulus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical patients
• Undergoing general anesthesia
• Able to consent in english
• years of age or older

You may not qualify if:

• Under 18 years of age
• unable to consent in english
• receiving regional anesthesia

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94134, United States

Location

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Results Point of Contact

• Title: Pekka Talke
• Organization: UCaliforniaSF

pekka.talke@ucsf.edu

4153063602

Study Officials

• Pekka Talke, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant will receive three tetanic stimuli. They are applied to the same three anatomical locations in each subject, but the order at which they are delivered to these locations will be random.

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: June 12, 2023
• Study Start: January 27, 2016
• Primary Completion: May 12, 2016
• Study Completion: May 12, 2016
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)