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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine | Active Comparator | Patients receiving phenylephrine for intraoperative hypotension |
|
| Norepinephrine | Active Comparator | Patients receiving norepinephrine for intraoperative hypotension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine | Drug | Intraoperative phenylephrine infusion Phenylephrine infusion to be titrated as needed to target a mean arterial pressure (MAP) > 65 mm Hg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vasopressor requirement | Total intraoperative vasopressor requirement | During inpatient admission |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative acute kidney injury | Kidney Disease Improving Global Outcomes (KDIGO) criteria Acute Kidney Injury (AKI) is defined as any of the following:
| During inpatient admission |
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Inclusion Criteria:
-Patients > 18 years undergoing elective, prone, spinal fusion surgery
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siddharth Dave, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clements University Hospital at Dallas | Dallas | Texas | 75235 | United States |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Norepinephrine | Drug | Intraoperative norepinephrine infusion Norepinephrine infusion to be titrated as needed to target a MAP > 65 mm Hg. |
|
| 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) |
| 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 |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |