Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study
NCT ID: NCT03719001
Last Updated: 2022-06-30
Study Results
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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COMPLETED
EARLY_PHASE1
40 participants
INTERVENTIONAL
2018-10-23
2022-06-15
Brief Summary
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Phenylephrine
Phenylephrine (100 ug/ml) infusion will be used to increase blood pressure by 20 mmHg
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
Dexmedetomidine
Dexmedetomidine infusion will be used to increase blood pressure by 20 mmHg
Dexmedetomidine
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
Clevidipine
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
Calcium Chloride
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
tetanic stimulus
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.
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.
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
Dexmedetomidine
blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca
Clevidipine
blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca
tetanic stimulus
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 with the pulse oximeter probes.
Calcium Chloride
CaCl will be administered to increase blood pressure and plasma calcium concentration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. unable to provide informed consent
3. Pregnancy
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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PT1802
Identifier Type: -
Identifier Source: org_study_id
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