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Completed

NCT Number: NCT06053398

Vasopressor Outcomes in Spine Surgery

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Clements University Hospital at Dallas

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Phenylephrine

Drug

Intraoperative phenylephrine infusion Phenylephrine infusion to be titrated as needed to target a mean arterial pressure (MAP) > 65 mm Hg.

norepinephrine

Drug

Intraoperative norepinephrine infusion Norepinephrine infusion to be titrated as needed to target a MAP > 65 mm Hg.

Primary outcomes

  1. Vasopressor requirement

    Time frame: During inpatient admission

    Total intraoperative vasopressor requirement

Secondary outcomes

  1. Postoperative acute kidney injury

    Time frame: During inpatient admission

    Kidney Disease Improving Global Outcomes (KDIGO) criteria

    Acute Kidney Injury (AKI) is defined as any of the following:

    • Increase in serum creatinine (sCr) ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours; or
    • Increase in sCr ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or
    • Urine volume <0.5 mL/kg/h for 6 hours
  2. Intraoperative transfusion requirement

    Time frame: During inpatient admission

  3. Postoperative vasopressor requirement

    Time frame: During inpatient admission

  4. Length of ICU stay

    Time frame: During inpatient admission

  5. Length of hospital stay

    Time frame: From admission to discharge (up to 100 weeks)

  6. 30-day readmission

    Time frame: 30-days post-discharge

  7. Postoperative Myocardial Injury

    Time frame: During inpatient admission

    Troponin elevation (ng/L)

  8. Postoperative Lactate Elevation

    Time frame: During inpatient admission

    Lactate (mmol/L)

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Acronym: V-SPINE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2023
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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