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NCT Number: NCT07796282

Phenylephrine Versus Norepinephrine in Spine Surgery: A Prospective Randomized Superiority Comparative Effectiveness Trial (SPiNeS)

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.

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Key information

Conditions

Spine Surgery Intraoperative Hypotension Tissue Perfusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Scheduled for elective complex spine surgery including posterior fusion of 5 or more levels of the thoracic and/or lumbar region.
  • ASA physical status classification I-III.
  • Able to provide informed consent.

Exclusion criteria

  • Known allergies or contraindication to NE or PE.
  • Pregnant or breastfeeding women.
  • Emergency surgeries.
  • Persistent atrial fibrillation
  • LVEF < 40%
  • Moderate or severe valvular dysfunction
  • RVSP ≥ 60 mm Hg
  • Liver failure or cirrhosis
  • eGFR < 15 and/or on hemodialysis
  • Minimally invasive or endoscopic surgeries

Treatment and study plan

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.

Primary outcomes

  1. Peak Intraoperative Serum Lactate

    Time frame: Intraoperatively, from initiation of lactate monitoring through final wound closure

    Highest intraoperative serum lactate concentration measured during surgery. Serum lactate will be analyzed as a continuous marker of tissue perfusion.

Secondary outcomes

  1. Incidence of Elevated Intraoperative Serum Lactate

    Time frame: Intraoperatively, from initiation of lactate monitoring through final wound closure

    Number of patients with presence of serum lactate greater than 2.0 mmol/L at any time during surgery.

  2. Postoperative Myocardial Injury After Noncardiac Surgery

    Time frame: Within 30 days after surgery

    Presence of postoperative myocardial injury after noncardiac surgery, defined as cardiac troponin greater than the 99th percentile of the upper reference limit and not attributable to a nonischemic cause.

  3. Postoperative Acute Kidney Injury

    Time frame: During postoperative hospitalization, up to 30 days after surgery

    Number of patients to be diagnosed with new acute kidney injury during postoperative hospitalization, based on KDIGO creatinine, urine output, renal replacement therapy, or hemodialysis criteria as specified in the protocol.

  4. Proportion of Intraoperative Hypotension

    Time frame: Intraoperatively, from surgical incision to turnover to anesthesia

    Duration of intraoperative MAP less than 85 mmHg divided by total surgical length, expressed as a percentage.

  5. Volume of Blood Transfusion

    Time frame: During surgery and within 24 hours postoperatively

    Total volume of blood transfusion, stratified by packed red blood cells, fresh frozen plasma, cryoprecipitate, platelets, and cell saver.

  6. Length of ICU Stay

    Time frame: From ICU admission to discharge from ICU-level care, up to 30 days after surgery

    Postoperative time during which the participant requires ICU-level care, reported in days.

  7. Length of Hospital Stay

    Time frame: From anesthesia end to hospital discharge, up to 30 days after surgery

    Time from anesthesia end until discharge to inpatient rehabilitation, skilled nursing facility, or home, reported in days.

  8. Quality of Recovery 15 (QoR-15) Score

    Time frame: 14 days post-operatively

    QoR-15 is an instrument that uses 15 questions regarding patient support, comfort, emotions, physical independence, and pain. Participants rate each question on a scale of 0 (none of the time) to 10 (all of the time).

  9. 30-Day Readmission Rate

    Time frame: Within 30 days after surgery

    Number of patients to be readmitted to the hospital for any reason on or before postoperative day 30.

  10. 30-Day All-Cause Mortality

    Time frame: Within 30 days after surgery

    Incidence of death from any cause within 30 days of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Mariel Anne Reyes

CONTACT

[email protected]

904-953-4797

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

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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