HypotensionEarly Phase 1V-SPINENCT06053398
Vasopressor Outcomes in Spine Surgery
A Early Phase 1 study testing Phenylephrine and Norepinephrine in people with Hypotension, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a prospective, randomized control trial comparing norepinephrine versus phenylephrine for vasopressor support in patients undergoing elective spinal fusion surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- What is being tested?
- Phenylephrine and Norepinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2023to 30 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- -Patients > 18 years undergoing elective, prone, spinal fusion surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clements University Hospital at Dallas
Dallas, Texas, 75235
About this study
This is a prospective, randomized control trial comparing norepinephrine versus phenylephrine for vasopressor support in patients undergoing elective spinal fusion surgery.
Read the 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.
- Conditions
- Hypotension
- Being tested
- Phenylephrine, Norepinephrine
- Keywords
- Vasopressor, Phenylephrine, Norepinephrine, Spine Surgery, General Anesthesia
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
Intraoperative phenylephrine infusion Phenylephrine infusion to be titrated as needed to target a mean arterial pressure (MAP) > 65 mm Hg.
NorepinephrineDrug
Intraoperative norepinephrine infusion Norepinephrine infusion to be titrated as needed to target a MAP > 65 mm Hg.
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Active comparator | Patients receiving phenylephrine for intraoperative hypotension Receives: Drug: Phenylephrine |
| Norepinephrine | Active comparator | Patients receiving norepinephrine for intraoperative hypotension Receives: Drug: Norepinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasopressor requirement
Total intraoperative vasopressor requirement
Measured: During inpatient admission
Secondary outcomes (8)
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
Measured: During inpatient admission
Intraoperative transfusion requirement
Measured: During inpatient admission
Postoperative vasopressor requirement
Measured: During inpatient admission
Length of ICU stay
Measured: During inpatient admission
Length of hospital stay
Measured: From admission to discharge (up to 100 weeks)
30-day readmission
Measured: 30-days post-discharge
Postoperative Myocardial Injury
Troponin elevation (ng/L)
Measured: During inpatient admission
Postoperative Lactate Elevation
Lactate (mmol/L)
Measured: During inpatient admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start21 Nov 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siddharth Dave, University of Texas Southwestern Medical Center
- Investigators
- Siddharth Dave, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053398
- Sponsor's protocol ID
- STU-2023-0326
- Acronym
- V-SPINE
- Status last verified
- Dec 2025
- First submitted
- 31 Aug 2023
- Last updated
- 30 Dec 2025
- Results posted
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasopressor Outcomes in Spine Surgery
- ClinicalTrials.gov ID
- NCT06053398
- Acronym / sponsor ID
- V-SPINE / STU-2023-0326
- Conditions
- Hypotension
- Keywords
- Vasopressor, Phenylephrine, Norepinephrine, Spine Surgery, General Anesthesia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 25 Sep 2023 (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.
This is a prospective, randomized control trial comparing norepinephrine versus phenylephrine for vasopressor support in patients undergoing elective spinal fusion surgery.
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 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: PhenylephrinePatients receiving phenylephrine for intraoperative hypotension |
| Norepinephrine | Active comparator | Drug: NorepinephrinePatients receiving norepinephrine for intraoperative hypotension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients > 18 years undergoing elective, prone, spinal fusion surgery
Key exclusion criteria (6 listed)
- Age < 18 years
- Emergency surgery
- Outpatient surgery
- Pregnancy
- End-stage renal disease requiring dialysis
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 |
|---|---|---|
| PhenylephrineIntraoperative phenylephrine infusion Phenylephrine infusion to be titrated as needed to target a mean arterial pressure (MAP) > 65 mm Hg. | Drug | Phenylephrine |
| NorepinephrineIntraoperative norepinephrine infusion Norepinephrine infusion to be titrated as needed to target a MAP > 65 mm Hg. | Drug | Norepinephrine |
Primary outcome
Vasopressor requirement
Time frame: During inpatient admission
Total intraoperative vasopressor requirement
8 secondary outcomes
Postoperative acute kidney injury
Time frame: During inpatient admission
Intraoperative transfusion requirement
Time frame: During inpatient admission
Postoperative vasopressor requirement
Time frame: During inpatient admission
Length of ICU stay
Time frame: During inpatient admission
Length of hospital stay
Time frame: From admission to discharge (up to 100 weeks)
30-day readmission
Time frame: 30-days post-discharge
Postoperative Myocardial Injury
Time frame: During inpatient admission
Postoperative Lactate Elevation
Time frame: During inpatient admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Hypotension
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RecruitingObservational study
Carotid Doppler Changes After Passive Leg Raising for Prediction of Post-Induction Hypotension in Gastrointestinal Tumor Surgery
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RecruitingObservational study
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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. This study is not recruiting at the moment.
Siddharth Dave, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Phenylephrine and Norepinephrine in people with Hypotension, run by University of Texas Southwestern Medical Center 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 30 Dec 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasopressor requirement (time frame: During inpatient admission). 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 30 Dec 2025.