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NCT07651956 · ClinicalTrials.gov registry record · Phase 4
Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial
A Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Not yet
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
NCT07651956: Clinical Trial Phase 4 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT07651956 is a Phase 4 study that has not yet begun recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 150 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07651956, a Phase 4 study, has not yet begun recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
Study Summary
Patients presenting for a scheduled cesarean delivery who require a neuraxial anesthetic will be randomized to receive intravenous remimazolam or dexmedetomidine for procedural sedation during the placement of their spinal or epidural anesthesia.
Primary Outcome
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), brady
Interventions
- DRUG Dexmedetomidine
- DRUG Remimazolam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2026-06 |
| Est. Completion | 2028-05 |
| Phase | Phase 4 |
What is known before NCT07651956 opens enrollment
NCT07651956 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (71% lower).
The record links to 0 conditions, and to 2 interventions - of which Dexmedetomidine is the first listed.
NCT07651956 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07651956 about?
NCT07651956 is a clinical study titled "Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial". Patients presenting for a scheduled cesarean delivery who require a neuraxial anesthetic will be randomized to receive intravenous remimazolam or dexmedetomidine for procedural sedation during the placement of their spinal or epidural anesthesia.
What is the current status of trial NCT07651956?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2026-06. Estimated completion is 2028-05.
What interventions are being tested in trial NCT07651956?
The interventions under investigation include: Dexmedetomidine (DRUG), Remimazolam (DRUG).
Who is sponsoring clinical trial NCT07651956?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07651956's enrollment target sits among peer trials
150 533rd of 2000 higher than 1,436 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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