Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study

June 29, 2022 updated by: University of California, San Francisco

A Pilot Study to Evaluate the Effect of Changing Physiological Conditions on the Amplitude and/or Frequency of Myogenic Oscillations

Spontaneous myogenic oscillations will be studied under general anesthesia using finger photoplethysmography. This pilot study will explore potential physiological conditions that will effect the amplitude and/or frequency of myogenic oscillations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single center, nonrandomized, nonblinded, interventional clinical pilot research study that plans to enroll 40 patients.

Study will be conducted while subjects are under general anesthesia.

Myogenic oscillations will be measured using finger photoplethysmography. Changes in the amplitude and/or frequency of these oscillations will be analyzed in response to the interventions. Arterial blood pressure will be recorded to verify the efficacy of the interventions.

Six different interventions that will either lower or increase blood pressure will be applied to the subjects. Each subject will receive 1 or 2 of the six interventions. Each of the 6 interventions will be applied to 8 subject.

The interventions that the subject will not be randomized. They will be determined by the subjects blood pressure immediately before the intervention to guarantee that the blood pressure manipulations are within a safe range.

Data will be analyzed offline using Matlab.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Early Phase 1

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, 94122
        • 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Over 18 yrs of age
  2. Undergoing surgery in Moffitt-Long operating rooms
  3. Receiving general anesthesia
  4. Will have an intra-arterial catheter for clinical purposes
  5. Able to consent in english

Exclusion Criteria:

  1. Under 18 years of age
  2. unable to provide informed consent
  3. Pregnancy

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: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Phenylephrine
Phenylephrine (100 ug/ml) infusion will be used to increase blood pressure by 20 mmHg
Drug: Phenylephrine
blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca channel blocker, CaCl, tetanic stimulus and increase in venous pressure
Other Names:
  • Neosynephrine
EXPERIMENTAL: Dexmedetomidine
Dexmedetomidine infusion will be used to increase blood pressure by 20 mmHg
Drug: Dexmedetomidine
blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca
Other Names:
  • Precedex
EXPERIMENTAL: Clevidipine
Clevidipine infusion will be used to increase blood pressure by 20 mmHg
Drug: Clevidipine
blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca
Other Names:
  • Cleviprex
EXPERIMENTAL: Calcium Chloride
Calcium Chloride will be administered to increase blood pressure and to increase blood calcium concentration
Drug: Calcium Chloride
CaCl will be administered to increase blood pressure and plasma calcium concentration
EXPERIMENTAL: tetanic stimulus
A 5 second 70 mA tetanic stimulus will be used to increase peripheral vascular tone
Other: tetanic stimulus
A 5 second 70 mA tetanic stimulus will be applied to elicit peripheral vasoconstriction (stress response)
EXPERIMENTAL: Increased venous pressure
A 5 minute inflation of a noninvasive blood pressure cuff to 30 mmHg to increase venous pressure in the arm.
Other: Increased venous pressure
A 5 minute inflation of a noninvasive blood pressure cuff to 30 mmHg to increase venous pressure in the arm with the pulse oximeter probes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
myogenic oscillations
Time Frame: up to 5 minutes
change in amplitude and/of frequency of myogenic oscillations
up to 5 minutes

Collaborators and Investigators

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

Sponsor

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)

October 23, 2018

Primary Completion (ACTUAL)

June 15, 2022

Study Completion (ACTUAL)

June 15, 2022

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

October 23, 2018

First Posted (ACTUAL)

October 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 29, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PT1802

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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