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Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial

NCT07651956 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-07-28

No results posted yet for this 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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Benjamin Hyers, MD · Icahn School of Medicine at Mount Sinai Department of Anesthesiology, Perioperative, and Pain Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-05-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07651956 on ClinicalTrials.gov