Remimazolam Versus Dexmedetomidine for Procedural Sedation During Neuraxial Anesthesia Placement For Scheduled Cesarean Delivery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sedation success
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patient scheduled for cesarean delivery
- •≥ 18 years old
- •≥ 37 weeks gestational age
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Dexmedetomidine (Drug)
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.
干预措施: Remimazolam (Drug)
结局指标
主要结局
Sedation success
时间窗: 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
次要结局
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- Number of fetal NICU admissions(Up to approximately 4 hours post-delivery.)
- Fetal APGAR scores(1 minute and 5 minutes after infant birth.)
- Umbilical artery/vein pH(Up to approximately 4 hours post-delivery.)
- Base excess(Up to approximately 4 hours post-delivery.)
研究者
Benjamin Hyers
Assistant Professor
Icahn School of Medicine at Mount Sinai