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Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study

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: NCT03719001
Recruitment Status : Enrolling by invitation
First Posted : October 25, 2018
Last Update Posted : December 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Vascular Diseases Drug: Phenylephrine Drug: Dexmedetomidine Drug: Clevidipine Other: tetanic stimulus Other: Increased venous pressure Drug: Calcium Chloride Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Pilot Study to Evaluate the Effect of Changing Physiological Conditions on the Amplitude and/or Frequency of Myogenic Oscillations
Actual Study Start Date : October 23, 2018
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

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 Name: 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 Name: 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 Name: 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.




Primary Outcome Measures :
  1. myogenic oscillations [ Time Frame: up to 5 minutes ]
    change in amplitude and/of frequency of myogenic oscillations



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:

  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

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): NCT03719001


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
Investigators
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Principal Investigator: Pekka Talke, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03719001    
Other Study ID Numbers: PT1802
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: December 17, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Clevidipine
Phenylephrine
Oxymetazoline
Dexmedetomidine
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Hypnotics and Sedatives
Central Nervous System Depressants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Mydriatics
Autonomic Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Protective Agents