NCT07796282

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
19mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Sep 2026May 2028

First Submitted

Initial submission to the registry

August 27, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

September 2, 2026

Status Verified

August 1, 2026

Enrollment Period

1.7 years

First QC Date

August 27, 2026

Last Update Submit

August 31, 2026

Conditions

Spine SurgeryIntraoperative HypotensionTissue Perfusion

Outcome Measures

Primary Outcomes (1)

  • Peak Intraoperative Serum Lactate

    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 Outcomes (10)

  • Incidence of Elevated Intraoperative Serum Lactate

    Intraoperatively, from initiation of lactate monitoring through final wound closure

  • Postoperative Myocardial Injury After Noncardiac Surgery

    Within 30 days after surgery

  • Postoperative Acute Kidney Injury

    During postoperative hospitalization, up to 30 days after surgery

  • Proportion of Intraoperative Hypotension

    Intraoperatively, from surgical incision to turnover to anesthesia

  • Volume of Blood Transfusion

    During surgery and within 24 hours postoperatively

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Drug: Norepinephrine bitartrate infusion

Interventions

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.

Norepinephrine
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.

Phenylephrine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Study Officials

  • Eric Deloso, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariel Anne Reyes

CONTACT

904-953-4797Reyes.Mariel@mayo.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2026

First Posted

September 1, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

September 2, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)