The purpose of this research is to compare two commonly used medications, phenylephrine and norepinephrine, that are used to treat low blood pressure during complex spine surgery. The goal is to determine whether one medication better maintains blood flow to the body's organs during surgery and whether it leads to better recovery and fewer complications after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Phenylephrine hydrochloride will be prepared at a concentration of 40 mcg/mL and initiated at 0.2 mcg/kg/min. The infusion will be titrated intraoperatively to maintain MAP greater than 85 mmHg from surgical manipulation of vertebrae until final wound closure.
Norepinephrine bitartrate will be prepared at a concentration of 16 mcg/mL, equivalent to 8.47 mcg/mL norepinephrine base, and initiated at 0.02 mcg/kg/min. The infusion will be titrated intraoperatively to maintain MAP greater than 85 mmHg from surgical manipulation of vertebrae until final wound closure.
Mayo Clinic
Jacksonville, Florida, United States
Peak Intraoperative Serum Lactate
Highest intraoperative serum lactate concentration measured during surgery. Serum lactate will be analyzed as a continuous marker of tissue perfusion.
Time frame: Intraoperatively, from initiation of lactate monitoring through final wound closure
Incidence of Elevated Intraoperative Serum Lactate
Number of patients with presence of serum lactate greater than 2.0 mmol/L at any time during surgery.
Time frame: Intraoperatively, from initiation of lactate monitoring through final wound closure
Postoperative Myocardial Injury After Noncardiac Surgery
Presence of postoperative myocardial injury after noncardiac surgery, defined as cardiac troponin greater than the 99th percentile of the upper reference limit and not attributable to a nonischemic cause.
Time frame: Within 30 days after surgery
Postoperative Acute Kidney Injury
Number of patients to be diagnosed with new acute kidney injury during postoperative hospitalization, based on KDIGO creatinine, urine output, renal replacement therapy, or hemodialysis criteria as specified in the protocol.
Time frame: During postoperative hospitalization, up to 30 days after surgery
Proportion of Intraoperative Hypotension
Duration of intraoperative MAP less than 85 mmHg divided by total surgical length, expressed as a percentage.
Time frame: Intraoperatively, from surgical incision to turnover to anesthesia
Volume of Blood Transfusion
Total volume of blood transfusion, stratified by packed red blood cells, fresh frozen plasma, cryoprecipitate, platelets, and cell saver.
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Time frame: During surgery and within 24 hours postoperatively
Length of ICU Stay
Postoperative time during which the participant requires ICU-level care, reported in days.
Time frame: From ICU admission to discharge from ICU-level care, up to 30 days after surgery
Length of Hospital Stay
Time from anesthesia end until discharge to inpatient rehabilitation, skilled nursing facility, or home, reported in days.
Time frame: From anesthesia end to hospital discharge, up to 30 days after surgery
Quality of Recovery 15 (QoR-15) Score
QoR-15 is an instrument that uses 15 questions regarding patient support, comfort, emotions, physical independence, and pain. Participants rate each question on a scale of 0 (none of the time) to 10 (all of the time).
Time frame: 14 days post-operatively
30-Day Readmission Rate
Number of patients to be readmitted to the hospital for any reason on or before postoperative day 30.
Time frame: Within 30 days after surgery
30-Day All-Cause Mortality
Incidence of death from any cause within 30 days of surgery
Time frame: Within 30 days after surgery