Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial

NCT07651956 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: STUDY-26-00500
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnant People; Anxiety

Keywords

Anxiolysis; Remimazolam; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Total sedation dose

  From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.

• Time to peak sedation

  From the initiation of the study drug until highest level of sedation, total sedation approximately 20 minutes.

• Richmond Agitation-Sedation Scale (RASS)

  Assessed at baseline and 1-minute intervals until baseline is restored, up to approximately 2 hours.

• Time to sedation recovery

  From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.

• Anxiety scores

  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.

Study Arms (2)

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.

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.

Drug: Dexmedetomidine

Interventions

Remimazolam DRUG

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.

Remimazolam

Dexmedetomidine DRUG

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.

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

remimazolam; Dexmedetomidine

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Benjamin Hyers, MD

  Icahn School of Medicine at Mount Sinai Department of Anesthesiology, Perioperative, and Pain Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Tran

CONTACT

917-767-2701; alexander.tran2@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: To maintain the integrity of data collection while ensuring patient safety, a multi-tier blinding strategy will be employed: * Blinded Research Member: Responsible for preoperative screening, obtaining informed consent, and all postoperative data collection (including the PACU survey). This individual will remain unaware of the study drug administered. * Unblinded Research Member: Responsible for informing the anesthesiologist of the allocation. This member will assist the anesthesiologist but will not participate in patient observation or data recording. * Unblinded Anesthesiologist: The clinician administering the anesthesia will be unblinded to the drug allocation to ensure patient safety.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)