Phenylephrine and Pulse Pressure Variability

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to determine how vasopressors affect a measure of how intravenous fluid is administered in people undergoing surgery who have low blood pressure called Pulse Pressure Variability (PPV). This study will recruit human subjects to undergo simulated hypovolemia called Lower Body Negative Pressure (LBNP) and will receive phenylephrine and placebo, while PPV will be measured in both conditions. This research will help anesthesiologists learn more about how to use PPV in patients undergoing surgery and who need vasopressors.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Texas Health Resources
• Treatments: Oxymetazoline; Phenylephrine

Criteria

Inclusion Criteria:

• 18 to 45 years of age

• Non-obese (Body Mass Index less than 30 kg/m2)

• Baseline systolic blood pressure between 80-140 mmHg

• Baseline diastolic blood pressure <90 mmHg

Exclusion Criteria:

• Participants who have cardiac, vascular, respiratory, neurological and/or metabolic illness

• Current or previous use of anti-hypertensive medications

• Any known history of renal or hepatic insufficiency/disease

• Pregnancy (verified by negative urine test on the experimental days) or breast-feeding

• Current smokers, as well as individuals who regularly smoked within the past 3 years

• Sulfite allergy, as this is a contraindication to intravenous phenylephrine

• Serious mental illness including claustrophobia

• History of use of recreational drugs including cocaine or amphetamines

• Peripheral vascular disease

• Subject on anticoagulant treatment

• Subjects with a baseline systolic blood pressure <80 mmHg