Superiority of Phenylephrine Versus Norepinephrine in Complex Spine Surgery (SPiNeS)

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT07796282
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Intraoperative Hypotension
  • Spine Surgery
  • Tissue Perfusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Phenylephrine hydrochloride infusion — 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 — 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

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.

Key Dates

First listed
Sep 1, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Phenylephrine
    Participants assigned to this group will undergo elective complex spine surgery with intraoperative blood pressure support managed using phenylephrine as the assigned first-line vasopressor strategy.
  • Experimental: Norepinephrine
    Participants assigned to this group will undergo elective complex spine surgery with intraoperative blood pressure support managed using norepinephrine as the assigned first-line vasopressor strategy.

Primary Outcome Measure

Peak Intraoperative Serum Lactate [ Time Frame: Intraoperatively, from initiation of lactate monitoring through final wound closure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicJacksonvilleFlorida32224
Mariel Anne Reyes
[email protected]
904-953-4797

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By research site
Mayo Clinic· Jacksonville, FL

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