Vasopressor Outcomes in Spine Surgery (V-SPINE)

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

Study Overview

• Status: Completed
• Conditions: Hypotension
• Intervention / Treatment: Drug: Phenylephrine; Drug: Norepinephrine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Clements University Hospital at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phenylephrine; Patients receiving phenylephrine for intraoperative hypotension	Drug: Phenylephrine; Intraoperative phenylephrine infusion Phenylephrine infusion to be titrated as needed to target a mean arterial pressure (MAP) > 65 mm Hg.
Active Comparator: Norepinephrine; Patients receiving norepinephrine for intraoperative hypotension	Drug: Norepinephrine; Intraoperative norepinephrine infusion Norepinephrine infusion to be titrated as needed to target a MAP > 65 mm Hg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vasopressor requirement	Total intraoperative vasopressor requirement	During inpatient admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative transfusion requirement		During inpatient admission
Postoperative vasopressor requirement		During inpatient admission
Length of ICU stay		During inpatient admission
30-day readmission		30-days post-discharge
Postoperative Myocardial Injury	Troponin elevation (ng/L)	During inpatient admission
Postoperative Lactate Elevation	Lactate (mmol/L)	During inpatient admission
Postoperative acute kidney injury	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	During inpatient admission
Length of hospital stay		From admission to discharge (up to 100 weeks)

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Siddharth Dave, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): December 30, 2025
• Last Update Submitted That Met QC Criteria: December 22, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Spine Surgery; Norepinephrine; General Anesthesia; Vasopressor; Phenylephrine
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Catechols; Phenols; Benzene Derivatives; Alcohols; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Norepinephrine; Phenylephrine
• Other Study ID Numbers: STU-2023-0326

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.: No