Intraoperative Hypotension, Spine Surgery, Tissue Perfusion
Conditions
Brief summary
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.
Interventions
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.
DRUGNorepinephrine bitartrate infusion
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.
Sponsors
Mayo Clinic
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
* Scheduled for elective complex spine surgery including posterior fusion of 5 or more levels of the thoracic and/or lumbar region. * ASA physical status classification I-III. * Able to provide informed consent.
Exclusion criteria
* Known allergies or contraindication to NE or PE. * Pregnant or breastfeeding women. * Emergency surgeries. * Persistent atrial fibrillation * LVEF \< 40% * Moderate or severe valvular dysfunction * RVSP ≥ 60 mm Hg * Liver failure or cirrhosis * eGFR \< 15 and/or on hemodialysis * Minimally invasive or endoscopic surgeries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Intraoperative Serum Lactate | Intraoperatively, from initiation of lactate monitoring through final wound closure | Highest intraoperative serum lactate concentration measured during surgery. Serum lactate will be analyzed as a continuous marker of tissue perfusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Elevated Intraoperative Serum Lactate | Intraoperatively, from initiation of lactate monitoring through final wound closure | Number of patients with presence of serum lactate greater than 2.0 mmol/L at any time during surgery. |
| Postoperative Myocardial Injury After Noncardiac Surgery | Within 30 days after 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. |
| Postoperative Acute Kidney Injury | During postoperative hospitalization, up to 30 days after surgery | 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. |
| Proportion of Intraoperative Hypotension | Intraoperatively, from surgical incision to turnover to anesthesia | Duration of intraoperative MAP less than 85 mmHg divided by total surgical length, expressed as a percentage. |
| Volume of Blood Transfusion | During surgery and within 24 hours postoperatively | Total volume of blood transfusion, stratified by packed red blood cells, fresh frozen plasma, cryoprecipitate, platelets, and cell saver. |
| Length of ICU Stay | From ICU admission to discharge from ICU-level care, up to 30 days after surgery | Postoperative time during which the participant requires ICU-level care, reported in days. |
| Length of Hospital Stay | From anesthesia end to hospital discharge, up to 30 days after surgery | Time from anesthesia end until discharge to inpatient rehabilitation, skilled nursing facility, or home, reported in days. |
| Quality of Recovery 15 (QoR-15) Score | 14 days post-operatively | 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). |
| 30-Day Readmission Rate | Within 30 days after surgery | Number of patients to be readmitted to the hospital for any reason on or before postoperative day 30. |
| 30-Day All-Cause Mortality | Within 30 days after surgery | Incidence of death from any cause within 30 days of surgery |
Countries
United States
Contacts
CONTACTMariel Anne Reyes
PRINCIPAL_INVESTIGATOREric Deloso, MD
Mayo Clinic
Outcome results
None listed