Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Pregnant People
• Intervention / Treatment: Drug: Remimazolam; Drug: Dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alexander Tran; Phone Number: 917-767-2701; Email: alexander.tran2@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
      • Contact: Alexander Tran; Phone Number: 917-767-2701; Email: alexander.tran2@mountsinai.org
      • Principal Investigator: Benjamin Hyers, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remimazolam; 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.	Drug: Remimazolam; 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.
Active Comparator: Dexmedetomidine; 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.	Drug: Dexmedetomidine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.)	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).	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).	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).	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.	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.	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.	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.	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.	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.	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.	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%.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Up to approximately 4 hours post-delivery.

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Benjamin Hyers, MD, Icahn School of Medicine at Mount Sinai Department of Anesthesiology, Perioperative, and Pain Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Remimazolam; Anxiolysis
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine; remimazolam
• Other Study ID Numbers: STUDY-26-00500

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes