Remimazolam vs. Dexmedetomidine for Sedation During Cesarean Delivery
This study is looking at two different medications, remimazolam and dexmedetomidine, to help pregnant people relax during a scheduled cesarean delivery. Both medications are given through an IV (into a vein) to help you reach a light level of sedation while you receive your spinal or epidural anesthesia. The main goal is to see which medication is more successful at providing good sedation. You may be able to join if you are at least 18 years old, are at least 37 weeks pregnant, and are scheduled for a cesarean delivery. The study is currently unclear on its recruitment status and plans to enroll 150 participants.
- Study design
- This is an interventional study where participants will be randomly assigned to receive either remimazolam or dexmedetomidine. The research team will be blinded to which medication you receive after the cesarean delivery.
- What's involved
- You will receive either remimazolam or dexmedetomidine through an IV during your spinal or epidural placement. Your vital signs and anxiety levels will be checked often, and you'll complete a short survey after delivery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your sedation success will be monitored from when you receive the study drug until you are discharged from the Post-Anesthesia Care Unit (PACU), up to about 4 hours after delivery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Benjamin Hyers, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai Department of Anesthesiology, Perioperative, and Pain Medicine
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Sedation successFrom the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
This will be a composite primary outcome that is patient focused with values "Yes" or "No." To achieve a "Yes" for sedation success, all the following components must be met: * Satisfaction of anxiolysis rated as ≥ 2 on a 9-point scale (where -4 = Completely Dissatisfied, 0 = Neutral, and +4 = Completely Satisfied) * Preserved memory of the birth * No vital sign changes during the neuraxial placement, defined as hypotension (SBP \< 80% of baseline), hypertension (SBP \> 120% of baseline), bradycardia (HR \< 60 bpm), tachycardia (HR \> 100 bpm), respiratory depression (RR \< 12 breaths/min), hypoxia (SpO2 \< 90%). Baseline is defined as pre-op vitals taken in the PACU. * Would get the medication again