Comparing dexmedetomidine and epinephrine for spinal anesthesia in cesarean sections
Comparison of Intrathecal Epinephrine Versus Dexmedetomidine as Adjuvants in Cesarean Section
This study is testing whether adding dexmedetomidine to spinal anesthesia can help pregnant women having a cesarean section manage pain just as well as using epinephrine.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06418308 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of adjunctive intrathecal dexmedetomidine versus epinephrine in enhancing single-dose spinal analgesia for cesarean sections. It focuses on pregnant patients aged 18-55 who are scheduled for either primary or secondary cesarean deliveries and are candidates for spinal anesthesia. The study will assess whether dexmedetomidine is non-inferior to epinephrine in terms of sensory block duration and postoperative pain management. By evaluating these two adjuncts, the research seeks to optimize anesthesia practices for cesarean sections.
Who should consider this trial
Good fit: Ideal candidates are pregnant patients aged 18-55 years scheduled for a cesarean section and eligible for single-shot spinal anesthesia.
Not a fit: Patients who may not benefit include those with contraindications to spinal anesthesia, such as coagulopathy or elevated intracranial pressure, and those undergoing emergency cesarean sections.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and anesthesia outcomes for patients undergoing cesarean sections.
How similar studies have performed: Previous studies have shown positive outcomes with similar adjuncts in spinal anesthesia, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant patients * aged 18-55 years * presenting for scheduled primary or secondary cesarean section * candidates for single shot spinal anesthesia singleton pregnancy Exclusion Criteria: * patient refusal of spinal anesthetic * if patient is not a candidate for spinal anesthesia due to history of coagulopathy, elevated intracranial pressure, infection at site of injection, etc. * emergency cesarean section * preexisting motor or sensory deficit * suspected pre-eclampsia * patient receiving combined spinal-epidural as anesthetic technique * BMI \> 40
Where this trial is running
New York, New York
- Mount Sinai Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Daniel Katz, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Talia Scott, MD
- Email: talia.scott@mountsinai.org
- Phone: 720-212-7448
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.