NCT06053398

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 21, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

August 31, 2023

Last Update Submit

December 22, 2025

Conditions

Hypotension

Keywords

VasopressorPhenylephrineNorepinephrineSpine SurgeryGeneral Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Vasopressor requirement

    Total intraoperative vasopressor requirement

    During inpatient admission

Secondary Outcomes (8)

  • Postoperative acute kidney injury

    During inpatient admission

  • Intraoperative transfusion requirement

    During inpatient admission

  • Postoperative vasopressor requirement

    During inpatient admission

  • Length of ICU stay

    During inpatient admission

  • Length of hospital stay

    From admission to discharge (up to 100 weeks)

  • +3 more secondary outcomes

Study Arms (2)

Phenylephrine

ACTIVE COMPARATOR

Patients receiving phenylephrine for intraoperative hypotension

Drug: Phenylephrine

Norepinephrine

ACTIVE COMPARATOR

Patients receiving norepinephrine for intraoperative hypotension

Drug: Norepinephrine

Interventions

PhenylephrineDRUG

Intraoperative phenylephrine infusion Phenylephrine infusion to be titrated as needed to target a mean arterial pressure (MAP) \> 65 mm Hg.

Phenylephrine
NorepinephrineDRUG

Intraoperative norepinephrine infusion Norepinephrine infusion to be titrated as needed to target a MAP \> 65 mm Hg.

Norepinephrine

Eligibility Criteria

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

You may qualify if:

  • Patients \> 18 years undergoing elective, prone, spinal fusion surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clements University Hospital at Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Hypotension

Interventions

PhenylephrineNorepinephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Siddharth Dave, MD

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 25, 2023

Study Start

November 21, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)