Hypotension
Conditions
Keywords
Vasopressor, Phenylephrine, Norepinephrine, Spine Surgery, General Anesthesia
Brief summary
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.
Interventions
DRUGPhenylephrine
Intraoperative phenylephrine infusion Phenylephrine infusion to be titrated as needed to target a mean arterial pressure (MAP) \> 65 mm Hg.
DRUGNorepinephrine
Intraoperative norepinephrine infusion Norepinephrine infusion to be titrated as needed to target a MAP \> 65 mm Hg.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vasopressor requirement | During inpatient admission | Total intraoperative vasopressor requirement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative transfusion requirement | During inpatient admission | — |
| Postoperative vasopressor requirement | During inpatient admission | — |
| Length of ICU stay | During inpatient admission | — |
| Postoperative acute kidney injury | During inpatient admission | Kidney Disease Improving Global Outcomes (KDIGO) criteria Acute Kidney Injury (AKI) is defined as any of the following: 1. Increase in serum creatinine (sCr) ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours; or 2. Increase in sCr ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or 3. Urine volume \<0.5 mL/kg/h for 6 hours |
| 30-day readmission | 30-days post-discharge | — |
| Postoperative Myocardial Injury | During inpatient admission | Troponin elevation (ng/L) |
| Postoperative Lactate Elevation | During inpatient admission | Lactate (mmol/L) |
| Length of hospital stay | From admission to discharge (up to 100 weeks) | — |
Countries
United States
Outcome results
None listed