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NCT Number: NCT03719001

Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study

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.

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Key information

Conditions

Vascular Diseases Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of California San Francisco

San Francisco, California, 94122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenylephrine

Drug

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

Dexmedetomidine

Drug

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

clevidipine

Drug

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

tetanic stimulus

Other

A 5 second 70 mA tetanic stimulus will be applied to elicit peripheral vasoconstriction (stress response)

Increased venous pressure

Other

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.

Calcium chloride

Drug

CaCl will be administered to increase blood pressure and plasma calcium concentration

Primary outcomes

  1. myogenic oscillations

    Time frame: up to 5 minutes

    change in amplitude and/of frequency of myogenic oscillations

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2018
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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