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Vasopressor Outcomes in Spine Surgery

NCT ID: NCT06053398

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-21

Study Completion Date

2024-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypotension

Keywords

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Vasopressor Phenylephrine Norepinephrine Spine Surgery General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phenylephrine

Patients receiving phenylephrine for intraoperative hypotension

Group Type ACTIVE_COMPARATOR

Phenylephrine

Intervention Type DRUG

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

Norepinephrine

Patients receiving norepinephrine for intraoperative hypotension

Group Type ACTIVE_COMPARATOR

Norepinephrine

Intervention Type DRUG

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

Interventions

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Phenylephrine

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

Intervention Type DRUG

Norepinephrine

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Siddharth Dave

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Siddharth Dave, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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Clements University Hospital at Dallas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU-2023-0326

Identifier Type: -

Identifier Source: org_study_id