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Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study

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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

Tracking Information
First Submitted Date  ICMJE October 23, 2018
First Posted Date  ICMJE October 25, 2018
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE October 23, 2018
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
myogenic oscillations [ Time Frame: up to 5 minutes ]
change in amplitude and/of frequency of myogenic oscillations
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study
Official Title  ICMJE A Pilot Study to Evaluate the Effect of Changing Physiological Conditions on the Amplitude and/or Frequency of Myogenic Oscillations
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Vascular Diseases
Intervention  ICMJE
  • 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
  • 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
  • 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
  • Other: tetanic stimulus
    A 5 second 70 mA tetanic stimulus will be applied to elicit peripheral vasoconstriction (stress response)
  • 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.
  • Drug: Calcium Chloride
    CaCl will be administered to increase blood pressure and plasma calcium concentration
Study Arms  ICMJE
  • Experimental: Phenylephrine
    Phenylephrine (100 ug/ml) infusion will be used to increase blood pressure by 20 mmHg
    Intervention: Drug: Phenylephrine
  • Experimental: Dexmedetomidine
    Dexmedetomidine infusion will be used to increase blood pressure by 20 mmHg
    Intervention: Drug: Dexmedetomidine
  • Experimental: Clevidipine
    Clevidipine infusion will be used to increase blood pressure by 20 mmHg
    Intervention: Drug: Clevidipine
  • Experimental: Calcium Chloride
    Calcium Chloride will be administered to increase blood pressure and to increase blood calcium concentration
    Intervention: Drug: Calcium Chloride
  • Experimental: tetanic stimulus
    A 5 second 70 mA tetanic stimulus will be used to increase peripheral vascular tone
    Intervention: Other: tetanic stimulus
  • Experimental: Increased venous pressure
    A 5 minute inflation of a noninvasive blood pressure cuff to 30 mmHg to increase venous pressure in the arm.
    Intervention: Other: Increased venous pressure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 23, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2022
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03719001
Other Study ID Numbers  ICMJE PT1802
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pekka Talke, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP