Superiority of Phenylephrine Versus Norepinephrine in Complex Spine Surgery (SPiNeS)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known allergies or contraindication to NE or PE.
Pregnant or breastfeeding women.
Emergency surgeries.
Persistent atrial fibrillation
Trial design
Design model
Parallel
Treatments tested in this trial
Phenylephrine hydrochloride infusion
DrugPhenylephrine 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 infusion
DrugNorepinephrine 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: PhenylephrineActive comparator 1 intervention
Group B: NorepinephrineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 closureSecondary outcomes
1
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 closure2
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 surgery3
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 surgery4
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 anesthesiaSponsors and contacts
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Source ClinicalTrials.gov
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