Pregnant PeoplePhase 4NCT07651956

Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial

A Phase 4 study testing Remimazolam and Dexmedetomidine in people with Pregnant People and Anxiety, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pregnant People, Anxiety
What is being tested?: Remimazolam and Dexmedetomidine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 150 participants
Where: 1 siteUnited States
Study dates: 25 Nov 2026to May 2028
Phase: Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Pregnant patient scheduled for cesarean delivery
≥ 18 years old
≥ 37 weeks gestational age

Who cannot join

Pregnant patients < 18 years old
Pregnant patients < 37 weeks gestational age
Has known hypersensitivity to benzodiazepines or dexmedetomidine
Has history of chronic benzodiazepine use or misuse

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alexander Tran contact

917-767-2701

alexander.tran2@mountsinai.org

United States1 site

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Alexander Tran, 917-767-2701, alexander.tran2@mountsinai.org
Benjamin Hyers, MD

Other trials in United States

About this study

Official title: Remimazolam Versus Dexmedetomidine for Procedural Sedation During Neuraxial Anesthesia Placement For Scheduled Cesarean Delivery

Read the detailed description

After obtaining consent, women presenting for scheduled cesarean delivery on the labor floor at Mount Sinai Hospital will be randomized into two groups to receive either remimazolam or dexmedetomidine. Baseline maternal demographic data, vital signs, and anxiety scores will be obtained. Prior to the placement of the spinal or epidural anesthesia, the unblinded clinical team will administer weight-based intravenous boluses of the assigned study medication, titrated to a target Richmond Agitation-Sedation Scale (RASS) score of -1 to -2. Maternal anxiety scores and vital signs will be continuously monitored at 5-minute intervals throughout the neuraxial placement procedure. Following the completion of the cesarean delivery, a blinded research member will administer a brief survey in the post-anesthesia care unit (PACU) to evaluate patient satisfaction and memory preservation.

Conditions: Pregnant People, Anxiety
Being tested: Remimazolam, Dexmedetomidine
Keywords: Anxiolysis, Remimazolam, Dexmedetomidine
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RemimazolamDrug
Administered via multiple weight-based intravenous boluses of 0.03 mg/kg over 1-2 minutes. Boluses are titrated sequentially until the patient reaches a target Richmond Agitation-Sedation Scale (RASS) score of -1 to -2. Once the target sedation window is initially achieved, the clinical anesthesiologist will ask the patient if they desire additional anxiolysis; additional boluses will be given only upon explicit patient request. Administration terminates immediately upon successful placement of the neuraxial block.
DexmedetomidineDrug
Administered via multiple weight-based intravenous boluses of 0.1 μg/kg over 1-2 minutes. Boluses are titrated sequentially until the patient reaches a target Richmond Agitation-Sedation Scale (RASS) score of -1 to -2. Once the target sedation window is initially achieved, the clinical anesthesiologist will ask the patient if they desire additional anxiolysis; additional boluses will be given only upon explicit patient request. Administration terminates immediately upon successful placement of the neuraxial block.

Study groups in NCT07651956
Study group	Role	What they receive
Remimazolam	Experimental	Participants randomized to this arm will receive intravenous remimazolam for procedural sedation prior to and during the placement of neuraxial anesthesia (spinal or epidural) for their scheduled cesarean delivery. Dosing will be titrated by an unblinded anesthesiologist to achieve a light target sedation level. Receives: Drug: Remimazolam
Dexmedetomidine	Active comparator	Participants randomized to this arm will receive intravenous dexmedetomidine for procedural sedation prior to and during the placement of neuraxial anesthesia (spinal or epidural) for their scheduled cesarean delivery. Dosing will be titrated by an unblinded anesthesiologist to achieve a light target sedation level. Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

Sedation success
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
Measured: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.

Secondary outcomes (21)

Total sedation dose
The total sedation dose used will be recorded for remimazolam in mg and mg/kg and dexmedetomidine in μg and μg/kg.
(The Richmond Agitation-Sedation Scale (RASS) scale score of 0 indicates that the participant is alert and calm.)
Measured: From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.
Time to peak sedation
The time to peak sedation will be defined as the time from start of sedation to highest Richmond Agitation-Sedation Scale (RASS) sedation score recorded. The Richmond Agitation-Sedation Scale (RASS) scale will be scored: 0 = alert and calm; -1 = drowsy (not fully alert, sustained (> 10 s) awareness with eye contact to voice); -2 = light sedation (awakens briefly (< 10 s) with eye contact to voice); -3 = moderate sedation (movement but no eye contact to voice); -4 = deep sedation (no response to voice, but eye opens or movement to physical stimulation); and -5 = unarousable (no response to voice or physical stimulation).
Measured: From the initiation of the study drug until highest level of sedation, total sedation approximately 20 minutes.
Richmond Agitation-Sedation Scale (RASS)
The participant's sedation score will be assessed using the Richmond Agitation-Sedation Scale (RASS) scale. A RASS score of 0 = alert and calm; -1 = drowsy (not fully alert, sustained (> 10 s) awareness with eye contact to voice); -2 = light sedation (awakens briefly (< 10 s) with eye contact to voice); -3 = moderate sedation (movement but no eye contact to voice); -4 = deep sedation (no response to voice, but eye opens or movement to physical stimulation); and -5 = unarousable (no response to voice or physical stimulation).
Measured: Assessed at baseline and 1-minute intervals until baseline is restored, up to approximately 2 hours.
Time to sedation recovery
The time to sedation recovery, which is the time between last minute of peak sedation (RASS -1 to -2) to baseline sedation (RASS 0), will be recorded. A Richmond Agitation-Sedation Scale (RASS) score of 0 = alert and calm; -1 = drowsy (not fully alert, sustained (> 10 s) awareness with eye contact to voice); -2 = light sedation (awakens briefly (< 10 s) with eye contact to voice); -3 = moderate sedation (movement but no eye contact to voice); -4 = deep sedation (no response to voice, but eye opens or movement to physical stimulation); and -5 = unarousable (no response to voice or physical stimulation).
Measured: From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.
Anxiety scores
Anxiety scores will be assessed via Likert scale 1-10. A higher score indicates higher level of anxiety.
Measured: From the initiation of the study drug at baseline, 1 minute, 5 minutes, 10 minutes, 15 minutes, 20 minutes until neuraxial completion, up to 20 minutes.
Iowa Satisfaction with Anesthesia Scale (ISAS)
Patient satisfaction will be assessed using a short survey given in the PACU after the cesarean delivery using the Iowa Satisfaction with Anesthesia Scale (ISAS). ISAS is scored as a mean of responses to 11 statements (e.g., "I felt pain," "I was satisfied with my anesthetic care"), yielding a single composite number. Each statement is measured from a range of -3 (not satisfied) to +3 (satisfied). A higher score indicates a higher patient satisfaction.
Measured: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Time for Neuraxial Placement
The time for neuraxial placement, which is the total time it takes for the anesthesiologist to complete placement of the neuraxial for the patient before cesarean delivery, will be recorded.
Measured: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Heart Rate
The patient's heart rate (HR) will be assessed.
Measured: Every 5 minutes from the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Mean Blood Pressure
The patient's mean blood pressure (MBP) will be assessed.
Measured: Every 5 minutes from the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Respiratory Rate
The patient's respiratory rate (RR) will be assessed.
Measured: Every 5 minutes from the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Oxygen Saturation
The patient's oxygen saturation (SpO2) will be assessed.
Measured: Every 5 minutes from the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of participants who experienced hypoxia
The presence of hypoxia will be accessed. Hypoxia will be defined as oxygen saturation (SpO2) < 90%.
Measured: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of participants who experienced hypotension
The presence of hypotension will be accessed. Hypotension is systolic blood pressure (SBP) < 80% of baseline.
Measured: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of participants who experienced tachycardia
The presence of tachycardia will be accessed. Tachycardia will be heart rate (HR) > 100 bpm.
Measured: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of participants who experienced bradycardia
The presence of bradycardia will be accessed. Bradycardia will be heart rate (HR) < 60 bpm.
Measured: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of participants who used vasoactive drugs (ephedrine, phenylephrine)
Vasoactive drugs (ephedrine, phenylephrine) are used if a patient has hypotension refractory to the standard care of fluids and prophylactic phenylephrine.
Measured: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of participants who needed flumazenil
Flumazenil is a reversal agent for remimazolam and used if the patient is clinically oversedated.
Measured: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
Number of fetal NICU admissions
The number of fetal NICU admissions will be recorded.
Measured: Up to approximately 4 hours post-delivery.
Fetal APGAR scores
The APGAR score is a cumulative score ranging from 0 to 10. A higher score indicates a better health outcome.
Measured: 1 minute and 5 minutes after infant birth.
Umbilical artery/vein pH
This is the pH of the umbilical artery and vein. Umbilical cord blood pH is a measure of the hydrogen ion concentration in the blood obtained from the umbilical artery and/or umbilical vein at birth. The pH scale is continuous, with a lower pH indicating greater acidemia. A lower pH may reflect increased fetal exposure to intrapartum hypoxia.
Measured: Up to approximately 4 hours post-delivery.
Base excess
Base excess in umbilical cord blood is a continuous measure reported in mmol/L (or mEq/L). A higher (less negative) base excess indicates more normal neonatal acid-base status, while a lower (more negative) base excess indicates greater metabolic acidosis, reflecting fetal oxygen deficit during labor and delivery.
Measured: Up to approximately 4 hours post-delivery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Nov 2026May 2028

First posted16 Jun 2026
Study start25 Nov 2026 (estimated)
Primary completionMay 2028 (estimated)
Study completionMay 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pregnant PeopleStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07651956
Sponsor's protocol ID: STUDY-26-00500
Status last verified: Sep 2026
First submitted: 11 Jun 2026
Last updated: 9 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: The IRB-approved informed consent document signed by participants explicitly states that the research team will never use or share personal information, study data, or samples for future research, even if all identifiers are removed. The consent terms strictly mandate that data will only be used to complete this specific study and will subsequently be destroyed.