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Spine SurgeryDrugPhase 4

What this study is

The purpose of this research is to compare two commonly used medications, phenylephrine and norepinephrine, that are used to treat low blood pressure during complex spine surgery. The goal is to determine whether one medication better maintains blood flow to the body's organs during surgery and whether it leads to better recovery and fewer complications after surgery.

What's being tested

  • Phenylephrine hydrochloride infusion

    Intervention · DRUG

    Phenylephrine hydrochloride will be prepared at a concentration of 40 mcg/mL and initiated at 0.2 mcg/kg/min. The infusion will be titrated intraoperatively to maintain MAP greater than 85 mmHg from surgical manipulation of vertebrae until final wound closure.

  • Norepinephrine bitartrate infusion

    Intervention · DRUG

    Norepinephrine bitartrate will be prepared at a concentration of 16 mcg/mL, equivalent to 8.47 mcg/mL norepinephrine base, and initiated at 0.02 mcg/kg/min. The infusion will be titrated intraoperatively to maintain MAP greater than 85 mmHg from surgical manipulation of vertebrae until final wound closure.

Study details

Official title
Superiority of Phenylephrine Versus Norepinephrine in Complex Spine Surgery (SPiNeS): A Prospective Randomized Superiority Trial
Sponsor
Mayo Clinic
Conditions
Spine Surgery · Intraoperative Hypotension · Tissue Perfusion
Enrolling
50 people
Starts
2026-09
Est. completion
2028-05
Design
Open-label, randomized, parallel groups, Phase 4
Record
View on ClinicalTrials.gov ↗