V-SPINE: Vasopressor Outcomes in Spine Surgery

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06053398

Collaborator

(none)

120

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypotension	Drug: Phenylephrine Drug: Norepinephrine	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Vasopressor Outcomes in Spine Surgery

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Phenylephrine Patients receiving phenylephrine for intraoperative hypotension	Drug: Phenylephrine Intraoperative phenylephrine infusion Phenylephrine infusion to be titrated as needed to target a mean arterial pressure (MAP) > 65 mm Hg.
Active Comparator: Norepinephrine Patients receiving norepinephrine for intraoperative hypotension	Drug: Norepinephrine Intraoperative norepinephrine infusion Norepinephrine infusion to be titrated as needed to target a MAP > 65 mm Hg.

Arm

Intervention/Treatment

Active Comparator: Phenylephrine

Patients receiving phenylephrine for intraoperative hypotension

Drug: Phenylephrine

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

Active Comparator: Norepinephrine

Patients receiving norepinephrine for intraoperative hypotension

Drug: Norepinephrine

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

Outcome Measures

Primary Outcome Measures

Vasopressor requirement [During inpatient admission]
Total intraoperative vasopressor requirement

Secondary Outcome Measures

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: 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
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 [During inpatient admission]
Troponin elevation (ng/L)
Postoperative Lactate Elevation [During inpatient admission]
Lactate (mmol/L)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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