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

August 31, 2026 updated by: Eric Deloso, Mayo Clinic

Superiority of Phenylephrine Versus Norepinephrine in Complex Spine Surgery (SPiNeS): A Prospective Randomized Superiority Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Phenylephrine hydrochloride infusion
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.
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.
Drug: Norepinephrine bitartrate infusion
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Intraoperatively, from initiation of lactate monitoring through final wound closure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Intraoperatively, from initiation of lactate monitoring through final wound closure
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.
Within 30 days after surgery
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.
During postoperative hospitalization, up to 30 days after surgery
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.
Intraoperatively, from surgical incision to turnover to anesthesia
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.
During surgery and within 24 hours postoperatively
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.
From ICU admission to discharge from ICU-level care, up to 30 days after surgery
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.
From anesthesia end to hospital discharge, up to 30 days after surgery
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).
14 days post-operatively
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.
Within 30 days after surgery
30-Day All-Cause Mortality
Time Frame: Within 30 days after surgery
Incidence of death from any cause within 30 days of surgery
Within 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric Deloso, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26-004084

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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