Clements University Hospital at Dallas
Dallas, Texas, 75235, United States
NCT Number: NCT06053398
This is a prospective, randomized control trial comparing norepinephrine versus phenylephrine for vasopressor support in patients undergoing elective spinal fusion surgery.
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Notify Me18 year and older
All sexes
Interventional
Early Phase 1
Dallas, Texas, 75235, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-Patients > 18 years undergoing elective, prone, spinal fusion surgery
Exclusion criteria
Intraoperative phenylephrine infusion Phenylephrine infusion to be titrated as needed to target a mean arterial pressure (MAP) > 65 mm Hg.
Intraoperative norepinephrine infusion Norepinephrine infusion to be titrated as needed to target a MAP > 65 mm Hg.
Time frame: During inpatient admission
Total intraoperative vasopressor requirement
Time frame: During inpatient admission
Kidney Disease Improving Global Outcomes (KDIGO) criteria
Acute Kidney Injury (AKI) is defined as any of the following:
Time frame: During inpatient admission
Time frame: During inpatient admission
Time frame: During inpatient admission
Time frame: From admission to discharge (up to 100 weeks)
Time frame: 30-days post-discharge
Time frame: During inpatient admission
Troponin elevation (ng/L)
Time frame: During inpatient admission
Lactate (mmol/L)
University of Texas Southwestern Medical Center
Other
Acronym: V-SPINE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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