Spine SurgeryPhase 4NCT07796282
Superiority of Phenylephrine Versus Norepinephrine in Complex Spine Surgery (SPiNeS)
A Phase 4 study testing Phenylephrine hydrochloride infusion and Norepinephrine bitartrate infusion in people with Spine Surgery and Intraoperative Hypotension, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Surgery, Intraoperative Hypotension, Tissue Perfusion
- What is being tested?
- Phenylephrine hydrochloride infusion and Norepinephrine bitartrate infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known allergies or contraindication to NE or PE.
- Pregnant or breastfeeding women.
- Emergency surgeries.
- Persistent atrial fibrillation
- LVEF < 40%
- Moderate or severe valvular dysfunction
Show all 10Show fewer
- RVSP ≥ 60 mm Hg
- Liver failure or cirrhosis
- eGFR < 15 and/or on hemodialysis
- Minimally invasive or endoscopic surgeries
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic
Jacksonville, Florida, 32224
Mariel Anne Reyes, 904-953-4797, Reyes.Mariel@mayo.edu
About this study
Official title: 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.
- Conditions
- Spine Surgery, Intraoperative Hypotension, Tissue Perfusion
- Being tested
- Phenylephrine hydrochloride infusion, Norepinephrine bitartrate infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenylephrine hydrochloride infusionDrug
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 infusionDrug
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 group | Role | What they receive |
|---|---|---|
| Phenylephrine | Active comparator | 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. Receives: Drug: Phenylephrine hydrochloride infusion |
| Norepinephrine | Experimental | 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. Receives: Drug: Norepinephrine bitartrate infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Intraoperative Serum Lactate
Highest intraoperative serum lactate concentration measured during surgery. Serum lactate will be analyzed as a continuous marker of tissue perfusion.
Measured: Intraoperatively, from initiation of lactate monitoring through final wound closure
Secondary outcomes (10)
Incidence of Elevated Intraoperative Serum Lactate
Number of patients with presence of serum lactate greater than 2.0 mmol/L at any time during surgery.
Measured: Intraoperatively, from initiation of lactate monitoring through final wound closure
Postoperative Myocardial Injury After Noncardiac 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.
Measured: Within 30 days after surgery
Postoperative Acute Kidney Injury
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.
Measured: During postoperative hospitalization, up to 30 days after surgery
Proportion of Intraoperative Hypotension
Duration of intraoperative MAP less than 85 mmHg divided by total surgical length, expressed as a percentage.
Measured: Intraoperatively, from surgical incision to turnover to anesthesia
Volume of Blood Transfusion
Total volume of blood transfusion, stratified by packed red blood cells, fresh frozen plasma, cryoprecipitate, platelets, and cell saver.
Measured: During surgery and within 24 hours postoperatively
Length of ICU Stay
Postoperative time during which the participant requires ICU-level care, reported in days.
Measured: From ICU admission to discharge from ICU-level care, up to 30 days after surgery
Length of Hospital Stay
Time from anesthesia end until discharge to inpatient rehabilitation, skilled nursing facility, or home, reported in days.
Measured: From anesthesia end to hospital discharge, up to 30 days after surgery
Quality of Recovery 15 (QoR-15) Score
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).
Measured: 14 days post-operatively
30-Day Readmission Rate
Number of patients to be readmitted to the hospital for any reason on or before postoperative day 30.
Measured: Within 30 days after surgery
30-Day All-Cause Mortality
Incidence of death from any cause within 30 days of surgery
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Deloso, Mayo Clinic
- Investigators
- Eric Deloso, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796282
- Sponsor's protocol ID
- 26-004084
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superiority of Phenylephrine Versus Norepinephrine in Complex Spine Surgery (SPiNeS): A Prospective Randomized Superiority Trial
- ClinicalTrials.gov ID
- NCT07796282
- Acronym / sponsor ID
- 26-004084
- Conditions
- Spine Surgery, Intraoperative Hypotension, Tissue Perfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Active comparator | Drug: Phenylephrine hydrochloride infusionParticipants 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. |
| Norepinephrine | Experimental | Drug: Norepinephrine bitartrate infusionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Known allergies or contraindication to NE or PE.
- Pregnant or breastfeeding women.
- Emergency surgeries.
- Persistent atrial fibrillation
- LVEF < 40%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenylephrine hydrochloride infusionPhenylephrine 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. | Drug | Phenylephrine |
| Norepinephrine bitartrate infusionNorepinephrine 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. | Drug | Norepinephrine |
Primary outcome
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.
10 secondary outcomes
Incidence of Elevated Intraoperative Serum Lactate
Time frame: Intraoperatively, from initiation of lactate monitoring through final wound closure
Postoperative Myocardial Injury After Noncardiac Surgery
Time frame: Within 30 days after surgery
Postoperative Acute Kidney Injury
Time frame: During postoperative hospitalization, up to 30 days after surgery
Proportion of Intraoperative Hypotension
Time frame: Intraoperatively, from surgical incision to turnover to anesthesia
Volume of Blood Transfusion
Time frame: 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
Length of Hospital Stay
Time frame: 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
30-Day Readmission Rate
Time frame: Within 30 days after surgery
30-Day All-Cause Mortality
Time frame: Within 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Spine Surgery
Not yet recruiting
Adding Different Doses of Dexmedetomidine to Bupivecaine in Erector Spinae Plane Block
Postoperative Pain in Lumbar Spine Surgery
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease
RecruitingPhase 4
Perioperative Rectal Methadone in Spine Surgery
Spinal Surgery, Post-operative Care
Not yet recruiting
MALMOS Technique for Selected Subaxial Cervical Spine Fractures
Cervical Spine Fractures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Deloso, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phenylephrine hydrochloride infusion and Norepinephrine bitartrate infusion in people with Spine Surgery and Intraoperative Hypotension, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariel Anne Reyes (904-953-4797, Reyes.Mariel@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Intraoperative Serum Lactate (time frame: Intraoperatively, from initiation of lactate monitoring through final wound closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.