Vascular DiseasesEarly Phase 1NCT03719001
Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study
A Early Phase 1 study testing Phenylephrine, Dexmedetomidine and Clevidipine in people with Vascular Diseases, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Phenylephrine, Dexmedetomidine and Clevidipine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2018to 15 Jun 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Under 18 years of age
- unable to provide informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94122
About this study
Official title: A Pilot Study to Evaluate the Effect of Changing Physiological Conditions on the Amplitude and/or Frequency of Myogenic Oscillations
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.
Read the 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.
- Conditions
- Vascular Diseases
- Being tested
- Phenylephrine, Dexmedetomidine, Clevidipine, tetanic stimulus, Increased venous pressure
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Also called Neosynephrine
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
DexmedetomidineDrug
Also called Precedex
blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca
ClevidipineDrug
Also called Cleviprex
blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca
tetanic stimulusOther
A 5 second 70 mA tetanic stimulus will be applied to elicit peripheral vasoconstriction (stress response)
Increased venous pressureOther
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 ChlorideDrug
CaCl will be administered to increase blood pressure and plasma calcium concentration
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Experimental | Phenylephrine (100 ug/ml) infusion will be used to increase blood pressure by 20 mmHg Receives: Drug: Phenylephrine |
| Dexmedetomidine | Experimental | Dexmedetomidine infusion will be used to increase blood pressure by 20 mmHg Receives: Drug: Dexmedetomidine |
| Clevidipine | Experimental | Clevidipine infusion will be used to increase blood pressure by 20 mmHg Receives: Drug: Clevidipine |
| Calcium Chloride | Experimental | Calcium Chloride will be administered to increase blood pressure and to increase blood calcium concentration Receives: Drug: Calcium Chloride |
| tetanic stimulus | Experimental | A 5 second 70 mA tetanic stimulus will be used to increase peripheral vascular tone Receives: Other: tetanic stimulus |
| Increased venous pressure | Experimental | A 5 minute inflation of a noninvasive blood pressure cuff to 30 mmHg to increase venous pressure in the arm. Receives: Other: Increased venous pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
myogenic oscillations
change in amplitude and/of frequency of myogenic oscillations
Measured: up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start23 Oct 2018
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pekka Talke, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719001
- Sponsor's protocol ID
- PT1802
- Status last verified
- Jun 2022
- First submitted
- 23 Oct 2018
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Effect of Changing Physiological Conditions on the Amplitude and/or Frequency of Myogenic Oscillations
- ClinicalTrials.gov ID
- NCT03719001
- Acronym / sponsor ID
- PT1802
- Conditions
- Vascular Diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Experimental | Drug: PhenylephrinePhenylephrine (100 ug/ml) infusion will be used to increase blood pressure by 20 mmHg |
| Dexmedetomidine | Experimental | Drug: DexmedetomidineDexmedetomidine infusion will be used to increase blood pressure by 20 mmHg |
| Clevidipine | Experimental | Drug: ClevidipineClevidipine infusion will be used to increase blood pressure by 20 mmHg |
| Calcium Chloride | Experimental | Drug: Calcium ChlorideCalcium Chloride will be administered to increase blood pressure and to increase blood calcium concentration |
| tetanic stimulus | Experimental | Other: tetanic stimulusA 5 second 70 mA tetanic stimulus will be used to increase peripheral vascular tone |
| Increased venous pressure | Experimental | Other: Increased venous pressureA 5 minute inflation of a noninvasive blood pressure cuff to 30 mmHg to increase venous pressure in the arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Under 18 years of age
- unable to provide informed consent
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenylephrineAlso: Neosynephrineblood 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 | Drug | Phenylephrine |
| DexmedetomidineAlso: Precedexblood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca | Drug | Dexmedetomidine |
| ClevidipineAlso: Cleviprexblood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca | Drug | Clevidipine |
| tetanic stimulusA 5 second 70 mA tetanic stimulus will be applied to elicit peripheral vasoconstriction (stress response) | Other | tetanic stimulus |
| Increased venous pressureA 5 minute inflation of a noninvasive blood pressure cuff to 30 mmHg to increase venous pressure in the arm with the pulse oximeter probes. | Other | Increased venous pressure |
| Calcium ChlorideCaCl will be administered to increase blood pressure and plasma calcium concentration | Drug | Calcium Chloride |
Primary outcome
myogenic oscillations
Time frame: up to 5 minutes
change in amplitude and/of frequency of myogenic oscillations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pekka Talke, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Phenylephrine, Dexmedetomidine and Clevidipine in people with Vascular Diseases, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myogenic oscillations (time frame: up to 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.