NCT03719001

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Oct 2018

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 23, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

3.6 years

First QC Date

October 23, 2018

Last Update Submit

June 29, 2022

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (1)

  • myogenic oscillations

    change in amplitude and/of frequency of myogenic oscillations

    up to 5 minutes

Study Arms (6)

Phenylephrine

EXPERIMENTAL

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

Drug: Phenylephrine

Dexmedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

Clevidipine

EXPERIMENTAL

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

Drug: Clevidipine

Calcium Chloride

EXPERIMENTAL

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

Drug: Calcium Chloride

tetanic stimulus

EXPERIMENTAL

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

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.

Other: Increased venous pressure

Interventions

PhenylephrineDRUG

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

Also known as: Neosynephrine
Phenylephrine
DexmedetomidineDRUG

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

Also known as: Precedex
Dexmedetomidine
ClevidipineDRUG

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

Also known as: Cleviprex
Clevidipine
tetanic stimulusOTHER

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

tetanic stimulus
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.

Increased venous pressure
Calcium ChlorideDRUG

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

Calcium Chloride

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Under 18 years of age
  • unable to provide informed consent
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94122, United States

Location

MeSH Terms

Conditions

Vascular Diseases

Interventions

PhenylephrineDexmedetomidineclevidipineCalcium Chloride

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCalcium CompoundsInorganic ChemicalsChloridesHydrochloric AcidChlorine Compounds

Study Officials

  • Pekka Talke, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2018

First Posted

October 25, 2018

Study Start

October 23, 2018

Primary Completion

June 15, 2022

Study Completion

June 15, 2022

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)