Anxiety, Pregnant People
Conditions
Keywords
Anxiolysis, Remimazolam, Dexmedetomidine
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.
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.
Interventions
DRUGRemimazolam
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.
DRUGDexmedetomidine
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
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sedation success | From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experienced hypoxia | From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery. | The presence of hypoxia will be accessed. Hypoxia will be defined as oxygen saturation (SpO2) \< 90%. |
| Number of participants who experienced hypotension | From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery. | The presence of hypotension will be accessed. Hypotension is systolic blood pressure (SBP) \< 80% of baseline. |
| Number of participants who experienced tachycardia | From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery. | The presence of tachycardia will be accessed. Tachycardia will be heart rate (HR) \> 100 bpm. |
| Number of participants who experienced bradycardia | From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery. | The presence of bradycardia will be accessed. Bradycardia will be heart rate (HR) \< 60 bpm. |
| Number of participants who used vasoactive drugs (ephedrine, 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. | Vasoactive drugs (ephedrine, phenylephrine) are used if a patient has hypotension refractory to the standard care of fluids and prophylactic phenylephrine. |
| Number of participants who needed flumazenil | From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery. | Flumazenil is a reversal agent for remimazolam and used if the patient is clinically oversedated. |
| Number of fetal NICU admissions | Up to approximately 4 hours post-delivery. | The number of fetal NICU admissions will be recorded. |
| Fetal APGAR scores | 1 minute and 5 minutes after infant birth. | The APGAR score is a cumulative score ranging from 0 to 10. A higher score indicates a better health outcome. |
| Total sedation dose | From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours. | 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 to peak sedation | From the initiation of the study drug until highest level of sedation, total sedation approximately 20 minutes. | 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). |
| Richmond Agitation-Sedation Scale (RASS) | Assessed at baseline and 1-minute intervals until baseline is restored, up to approximately 2 hours. | 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 to sedation recovery | From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours. | 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). |
| 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. | Anxiety scores will be assessed via Likert scale 1-10. A higher score indicates higher level of anxiety. |
| Iowa Satisfaction with Anesthesia Scale (ISAS) | From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery. | 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. |
| Time for Neuraxial Placement | From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery. | 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. |
| Heart Rate | 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. | The patient's heart rate (HR) will be assessed. |
| Mean Blood Pressure | 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. | The patient's mean blood pressure (MBP) will be assessed. |
| Respiratory Rate | 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. | The patient's respiratory rate (RR) will be assessed. |
| Umbilical artery/vein pH | Up to approximately 4 hours post-delivery. | 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. |
| Oxygen Saturation | 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. | The patient's oxygen saturation (SpO2) will be assessed. |
| Base excess | Up to approximately 4 hours post-delivery. | 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. |
Countries
United States
Contacts
CONTACTAlexander Tran
PRINCIPAL_INVESTIGATORBenjamin Hyers, MD
Icahn School of Medicine at Mount Sinai Department of Anesthesiology, Perioperative, and Pain Medicine
Outcome results
None listed