NCT03719001

Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	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
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
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
OTHER	tetanic stimulus	A 5 second 70 mA tetanic stimulus will be applied to elicit peripheral vasoconstriction (stress response)
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.
DRUG	Calcium Chloride	CaCl will be administered to increase blood pressure and plasma calcium concentration

Timeline

• Start date: 2018-10-23
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2018-10-25
• Last updated: 2022-06-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study