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Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study

Primary Purpose

Vascular Diseases

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Phenylephrine
Dexmedetomidine
Clevidipine
tetanic stimulus
Increased venous pressure
Calcium Chloride
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Vascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Phenylephrine

Dexmedetomidine

Clevidipine

Calcium Chloride

tetanic stimulus

Increased venous pressure

Arm Description

Phenylephrine (100 ug/ml) infusion will be used to increase blood pressure by 20 mmHg

Dexmedetomidine infusion will be used to increase blood pressure by 20 mmHg

Clevidipine infusion will be used to increase blood pressure by 20 mmHg

Calcium Chloride will be administered to increase blood pressure and to increase blood calcium concentration

A 5 second 70 mA tetanic stimulus will be used to increase peripheral vascular tone

A 5 minute inflation of a noninvasive blood pressure cuff to 30 mmHg to increase venous pressure in the arm.

Outcomes

Primary Outcome Measures

myogenic oscillations
change in amplitude and/of frequency of myogenic oscillations

Secondary Outcome Measures

Full Information

First Posted
October 23, 2018
Last Updated
June 29, 2022
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03719001
Brief Title
Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study
Official Title
A Pilot Study to Evaluate the Effect of Changing Physiological Conditions on the Amplitude and/or Frequency of Myogenic Oscillations
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (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
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phenylephrine
Arm Type
Experimental
Arm Description
Phenylephrine (100 ug/ml) infusion will be used to increase blood pressure by 20 mmHg
Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Dexmedetomidine infusion will be used to increase blood pressure by 20 mmHg
Arm Title
Clevidipine
Arm Type
Experimental
Arm Description
Clevidipine infusion will be used to increase blood pressure by 20 mmHg
Arm Title
Calcium Chloride
Arm Type
Experimental
Arm Description
Calcium Chloride will be administered to increase blood pressure and to increase blood calcium concentration
Arm Title
tetanic stimulus
Arm Type
Experimental
Arm Description
A 5 second 70 mA tetanic stimulus will be used to increase peripheral vascular tone
Arm Title
Increased venous pressure
Arm Type
Experimental
Arm Description
A 5 minute inflation of a noninvasive blood pressure cuff to 30 mmHg to increase venous pressure in the arm.
Intervention Type
Drug
Intervention Name(s)
Phenylephrine
Other Intervention Name(s)
Neosynephrine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca
Intervention Type
Drug
Intervention Name(s)
Clevidipine
Other Intervention Name(s)
Cleviprex
Intervention Description
blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca
Intervention Type
Other
Intervention Name(s)
tetanic stimulus
Intervention Description
A 5 second 70 mA tetanic stimulus will be applied to elicit peripheral vasoconstriction (stress response)
Intervention Type
Other
Intervention Name(s)
Increased venous pressure
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcium Chloride
Intervention Description
CaCl will be administered to increase blood pressure and plasma calcium concentration
Primary Outcome Measure Information:
Title
myogenic oscillations
Description
change in amplitude and/of frequency of myogenic oscillations
Time Frame
up to 5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 yrs of age Undergoing surgery in Moffitt-Long operating rooms Receiving general anesthesia Will have an intra-arterial catheter for clinical purposes Able to consent in english Exclusion Criteria: Under 18 years of age unable to provide informed consent Pregnancy
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
94122
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study

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