Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study

NCT ID: NCT03719001

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-23

Study Completion Date

2022-06-15

Brief Summary

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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

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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.

Conditions

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Vascular Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Phenylephrine

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

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type 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

Dexmedetomidine

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca

Clevidipine

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

Group Type EXPERIMENTAL

Clevidipine

Intervention Type DRUG

blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca

Calcium Chloride

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

Group Type EXPERIMENTAL

Calcium Chloride

Intervention Type DRUG

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

tetanic stimulus

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

Group Type EXPERIMENTAL

tetanic stimulus

Intervention Type OTHER

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

Increased venous pressure

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

Group Type EXPERIMENTAL

Increased venous pressure

Intervention Type 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.

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

tetanic stimulus

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

Intervention Type 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.

Intervention Type OTHER

Calcium Chloride

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

Intervention Type DRUG

Other Intervention Names

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Neosynephrine Precedex Cleviprex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pekka Talke, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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PT1802

Identifier Type: -

Identifier Source: org_study_id

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