Actively Recruiting
Comparison of Intrathecal Epinephrine Versus Dexmedetomidine as Additives in Spinal Anesthesia During Cesarean Section
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-01-07
62
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of two different drugs, dexmedetomidine and epinephrine, added to a standard spinal anesthesia mixture for cesarean section. The study aims to determine if dexmedetomidine is not worse than epinephrine in providing effective spinal analgesia during cesarean deliveries. This research addresses a gap, as no prior studies have directly compared these two drugs as additives in single-dose spinal analgesia. Participants will receive either 5 mcg of dexmedetomidine or 200 mcg of epinephrine added to the standard spinal mixture, which includes hyperbaric bupivacaine and morphine. This is a randomized, quadruple-blinded study comparing these two active treatments. The spinal anesthesia is given as a single shot during scheduled cesarean sections. During the study, participants will be closely monitored for sensory recovery time, pain levels at various stages of surgery, blood pressure, heart rate, and other vital signs up to 270 minutes after spinal anesthesia. Researchers will also assess opioid use, patient satisfaction, newborn Apgar scores, and any side effects like nausea or shivering. The total study participation includes monitoring during surgery and follow-up assessments up to 24 hours after the procedure.
CONDITIONS
Brief Title
Intrathecal Dexmedetomidine vs Epinephrine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant patients
- Aged 18 to 55 years
- Scheduled for primary or secondary cesarean section
- Candidates for single-shot spinal anesthesia
- Singleton pregnancy
You will not qualify if you...
- Refusal of spinal anesthesia
- Not a candidate for spinal anesthesia due to coagulopathy, elevated intracranial pressure, infection at injection site, or similar conditions
- Emergency cesarean section
- Preexisting motor or sensory deficit
- Suspected pre-eclampsia
- Receiving combined spinal-epidural anesthesia
- Body mass index (BMI) greater than 40
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 150 minutes
Participants receive a single-shot spinal anesthesia with either dexmedetomidine or epinephrine added to a standardized spinal medication mixture during cesarean section.
1 in-person treatment visit during surgery
Duration - Up to 24 hours
Participants are monitored for recovery, side effects, and satisfaction after the surgery.
1 post-operative visit on Day 1
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
Research Team
T
Talia Scott, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here