Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial

Conditions

• Anxiety
• Pregnant People

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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.

Study Details

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.

Key Dates

Start date

Jun 30, 2026

Status verified

Jun 2026

Primary completion

May 31, 2028

Completion

May 31, 2028

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

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

Central Contacts

• Alexander Tran
  917-767-2701
  [email protected]

Locations (1)

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