Comparing vasopressors for patients undergoing spine surgery
Vasopressor Outcomes in Spine Surgery
EARLY_PHASE1 · University of Texas Southwestern Medical Center · NCT06053398
This study is testing whether norepinephrine or phenylephrine is better for helping patients feel stable during and after spine surgery.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06053398 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, randomized control study that compares the effects of norepinephrine and phenylephrine as vasopressor support in patients undergoing elective spinal fusion surgery. The research aims to address the limited evidence regarding postoperative outcomes related to the choice of vasopressor in this specific surgical context. By evaluating the differential outcomes of these two vasopressors, the study seeks to provide insights into their safety and efficacy during complex spinal surgeries performed under general anesthesia. The trial will include patients over 18 years old who are undergoing surgery in the prone position.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 18 years old undergoing elective spinal fusion surgery in the prone position.
Not a fit: Patients who may not benefit include those under 18 years old, those requiring emergency surgery, or those with specific cardiac or renal conditions.
Why it matters
Potential benefit: If successful, this study could help determine the most effective vasopressor for improving postoperative outcomes in spinal surgery patients.
How similar studies have performed: While previous studies have explored vasopressor use in non-cardiac surgeries, this specific comparison in spinal surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dallas, Texas
- Clements University Hospital at Dallas — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Siddharth Dave, MD — UT Southwestern Medical Center
- Study coordinator: Siddharth Dave, MD
- Email: siddharth.dave@utsouthwestern.edu
- Phone: 6469321770
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypotension, Vasopressor, Phenylephrine, Norepinephrine, Spine Surgery, General Anesthesia