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Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial

2026年9月8日 更新者：Benjamin Hyers、Icahn School of Medicine at Mount Sinai

Remimazolam Versus Dexmedetomidine for Procedural Sedation During Neuraxial Anesthesia Placement For Scheduled Cesarean Delivery

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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

150

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • New York
      • New York、New York、アメリカ、10029
        • Icahn School of Medicine at Mount Sinai
        • コンタクト：
        • 主任研究者：
          • Benjamin Hyers, MD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
薬：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.
アクティブコンパレータ：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.
薬：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Sedation success
時間枠：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
From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.

二次結果の測定

結果測定
メジャーの説明
時間枠
Total sedation dose
時間枠：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.)
From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.
Time to peak sedation
時間枠：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).
From the initiation of the study drug until highest level of sedation, total sedation approximately 20 minutes.
Richmond Agitation-Sedation Scale (RASS)
時間枠：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).
Assessed at baseline and 1-minute intervals until baseline is restored, up to approximately 2 hours.
Time to sedation recovery
時間枠：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).
From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.
Anxiety scores
時間枠：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.
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)
時間枠：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.
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
時間枠：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.
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
時間枠：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.
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
時間枠：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.
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
時間枠：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.
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
時間枠：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.
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
時間枠：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%.
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
時間枠：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.
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
時間枠：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.
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
時間枠：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.
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)
時間枠：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.
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
時間枠：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.
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
時間枠：Up to approximately 4 hours post-delivery.
The number of fetal NICU admissions will be recorded.
Up to approximately 4 hours post-delivery.
Fetal APGAR scores
時間枠：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.
1 minute and 5 minutes after infant birth.
Umbilical artery/vein pH
時間枠：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.
Up to approximately 4 hours post-delivery.
Base excess
時間枠：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.
Up to approximately 4 hours post-delivery.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Icahn School of Medicine at Mount Sinai

捜査官

  • 主任研究者：Benjamin Hyers, MD、Icahn School of Medicine at Mount Sinai Department of Anesthesiology, Perioperative, and Pain Medicine

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月25日

一次修了 (推定)

2028年5月1日

研究の完了 (推定)

2028年5月1日

試験登録日

最初に提出

2026年6月11日

QC基準を満たした最初の提出物

2026年6月11日

最初の投稿 (実際)

2026年6月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月9日

QC基準を満たした最後の更新が送信されました

2026年9月8日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • STUDY-26-00500

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

The IRB-approved informed consent document signed by participants explicitly states that the research team will never use or share personal information, study data, or samples for future research, even if all identifiers are removed. The consent terms strictly mandate that data will only be used to complete this specific study and will subsequently be destroyed.

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米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

はい

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