Vasopressor Outcomes in Spine Surgery

Last updated: June 23, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Active - Recruiting

Phase

1

Condition

Circulation Disorders

Vascular Diseases

Dizzy/fainting Spells

Treatment

Norepinephrine

Phenylephrine

Clinical Study ID

NCT06053398
STU-2023-0326
  • Ages > 18
  • All Genders

Study Summary

This is a prospective, randomized control trial comparing norepinephrine versus phenylephrine for vasopressor support in patients undergoing elective spinal fusion surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

-Patients > 18 years undergoing elective, prone, spinal fusion surgery

Exclusion

Exclusion Criteria:

  • Age < 18 years

  • Emergency surgery

  • Outpatient surgery

  • Pregnancy

  • End-stage renal disease requiring dialysis

  • Diagnosed myocardial ischemia and/or cardiac revascularization within the past month

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Norepinephrine
Phase: 1
Study Start date:
November 21, 2023
Estimated Completion Date:
December 01, 2025

Study Description

There is limited evidence on the difference in postoperative outcomes between the choices of vasopressors used to treat intraoperative hypotension (IOH) in patients undergoing non-cardiac surgery under general anesthesia. A recent pilot feasibility trial comparing norepinephrine and phenylephrine for first-line intravenous infusion of vasopressor during general anesthesia and major non-cardiac surgery was unable to show any difference in postoperative outcomes. Although the study demonstrated safety and feasibility, it was not powered to detect differences in postoperative outcomes. The impact of vasopressors on postoperative outcomes in patients undergoing complex spinal surgery in the prone position is even scarcer. While it has been demonstrated that the use of intra-operative vasopressor infusion is safe and well tolerated, without any adverse renal outcomes, it is unclear if the choice of vasopressor makes any difference. While animal studies have shown that norepinephrine may provide greater spinal cord protection than phenylephrine, clinical studies in humans are lacking. We aim to fill this gap in knowledge by carrying out a prospective, randomized control trial to evaluate differential outcomes related to the choice of norepinephrine versus phenylephrine as the preferential vasopressor in patients undergoing elective spinal fusion surgery in the prone position.

Connect with a study center

  • Clements University Hospital at Dallas

    Dallas, Texas 75235
    United States

    Active - Recruiting

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