Clinical trial NCT06053398: Vasopressor Outcomes in Spine Surgery
Official title: Vasopressor Outcomes in Spine Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Hypotension
Keywords: Vasopressor
Phenylephrine
Norepinephrine
Spine Surgery
General Anesthesia
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vasopressor requirement
timeFrame: During inpatient admission
Secondary outcomes:
measure: Postoperative acute kidney injury
timeFrame: During inpatient admission
measure: Intraoperative transfusion requirement
timeFrame: During inpatient admission
measure: Postoperative vasopressor requirement
timeFrame: During inpatient admission
measure: Length of ICU stay
timeFrame: During inpatient admission
measure: Length of hospital stay
timeFrame: From admission to discharge (up to 100 weeks)
measure: 30-day readmission
timeFrame: 30-days post-discharge
measure: Postoperative Myocardial Injury
timeFrame: During inpatient admission
measure: Postoperative Lactate Elevation
timeFrame: During inpatient admission
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Clements University Hospital at Dallas
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Siddharth Dave, MD
role: PRINCIPAL_INVESTIGATOR
References: