Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIcahn School of Medicine at Mount Sinai
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant patient scheduled for cesarean delivery
≥ 18 years old
≥ 37 weeks gestational age
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Remimazolam
DrugAdministered 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
DrugAdministered 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: RemimazolamExperimental treatment 1 intervention
Group B: DexmedetomidineActive comparator 1 intervention
Trial outcomes
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
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.Secondary outcomes
1
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.)
Time frame
From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.2
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).
Time frame
From the initiation of the study drug until highest level of sedation, total sedation approximately 20 minutes.3
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).
Time frame
Assessed at baseline and 1-minute intervals until baseline is restored, up to approximately 2 hours.4
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).
Time frame
From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.Sponsors and contacts
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Source ClinicalTrials.gov
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