Effect of Changing Physiological Conditions on Myogenic Oscillations: Pilot Study

Early Phase 1

Completed

• Conditions: Vascular Diseases
• Interventions: Other: Increased venous pressure; Drug: Clevidipine; Other: tetanic stimulus; Drug: Phenylephrine; Drug: Dexmedetomidine; Drug: Calcium Chloride

• Registration Number: NCT03719001
• Lead Sponsor: University of California, San Francisco

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.

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 Timeline

• Study Start: 2018-10-23
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Status Verified: 2022-06
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

1. Under 18 years of age
2. unable to provide informed consent
3. Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Increased venous pressure	Increased venous pressure	A 5 minute inflation of a noninvasive blood pressure cuff to 30 mmHg to increase venous pressure in the arm.
Clevidipine	Clevidipine	Clevidipine infusion will be used to increase blood pressure by 20 mmHg
tetanic stimulus	tetanic stimulus	A 5 second 70 mA tetanic stimulus will be used to increase peripheral vascular tone
Phenylephrine	Phenylephrine	Phenylephrine (100 ug/ml) infusion will be used to increase blood pressure by 20 mmHg
Dexmedetomidine	Dexmedetomidine	Dexmedetomidine infusion will be used to increase blood pressure by 20 mmHg
Calcium Chloride	Calcium Chloride	Calcium Chloride will be administered to increase blood pressure and to increase blood calcium concentration

Primary Outcome Measures

Name	Time	Method
myogenic oscillations	up to 5 minutes	change in amplitude and/of frequency of myogenic oscillations

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States