Vasopressor Outcomes in Spine Surgery

Early Phase 1

Recruiting

• Conditions: Hypotension
• Interventions: Drug: Phenylephrine; Drug: Norepinephrine

• Registration Number: NCT06053398
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-25
• Study Start: 2023-11-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenylephrine	Phenylephrine	Patients receiving phenylephrine for intraoperative hypotension
Norepinephrine	Norepinephrine	Patients receiving norepinephrine for intraoperative hypotension

Primary Outcome Measures

Name	Time	Method
Vasopressor requirement	During inpatient admission	Total intraoperative vasopressor requirement

Secondary Outcome Measures

Name	Time	Method
Postoperative Myocardial Injury	During inpatient admission	Troponin elevation (ng/L)
Postoperative Lactate Elevation	During inpatient admission	Lactate (mmol/L)
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 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
Intraoperative transfusion requirement	During inpatient admission
Postoperative vasopressor requirement	During inpatient admission

Trial Locations

Locations (1)

Clements University Hospital at Dallas; 🇺🇸 Dallas, Texas, United States