Intrathecal Dexmedetomidine vs Epinephrine (NCT06418308) | Clinical Trial Compass
CompletedPhase 4
Intrathecal Dexmedetomidine vs Epinephrine
United States90 participantsStarted 2024-09-17
Plain-language summary
Several studies have shown that adding dexmedetomidine or epinephrine to single-dose spinal analgesia preparations improves the length and/or speed of onset of the sensory block and post-operative pain management without increased negative side effects. To date, however, no study has compared adjunctive intrathecal dexmedetomidine to adjunctive intrathecal epinephrine in single-dose spinal analgesia. The purpose of this study is to determine if adjunctive intrathecal dexmedetomidine is non-inferior to adjunctive intrathecal epinephrine in providing better single-dose spinal analgesia during cesarean section.
Who can participate
Age range
18 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared dexmedetomidine and epinephrine given directly into the spinal space during cesarean section — can you explain how these two additives differ, and which one you typically use in my case and why?
2Since this was a Phase 4 trial, meaning both drugs were already approved and in use, does the completed research give you any new information about how long spinal anesthesia lasts or how quickly sensation returns after a cesarean, and how might that affect my recovery experience?
3The trial measured how long it takes for feeling to come back after spinal anesthesia — is a longer or shorter sensory recovery time better for someone in my situation, and what are the trade-offs I should understand?
4Are there any safety signals or side effects associated with intrathecal dexmedetomidine specifically that came out of completed studies like this one, and how would those risks apply to me given my health history?
5Since this trial is already completed, would the findings change anything about the spinal anesthesia approach my care team is planning for my cesarean, or is standard practice in my hospital already aligned with what the research found?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.