Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial
2026년 9월 8일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
150
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Alexander Tran
- 전화번호: 917-767-2701
- 이메일: alexander.tran2@mountsinai.org
연구 장소
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New York
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New York, New York, 미국, 10029
- Icahn School of Medicine at Mount Sinai
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연락하다:
- Alexander Tran
- 전화번호: 917-767-2701
- 이메일: alexander.tran2@mountsinai.org
-
수석 연구원:
- Benjamin Hyers, MD
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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활성 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sedation success
기간: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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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:
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total sedation dose
기간: From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.
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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.
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Time to peak sedation
기간: From the initiation of the study drug until highest level of sedation, total sedation approximately 20 minutes.
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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).
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From the initiation of the study drug until highest level of sedation, total sedation approximately 20 minutes.
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Richmond Agitation-Sedation Scale (RASS)
기간: Assessed at baseline and 1-minute intervals until baseline is restored, up to approximately 2 hours.
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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).
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Assessed at baseline and 1-minute intervals until baseline is restored, up to approximately 2 hours.
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Time to sedation recovery
기간: From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.
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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).
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From the initiation of the study drug until return to baseline sedation (RASS 0), up to approximately 2 hours.
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Anxiety scores
기간: 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.
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Anxiety scores will be assessed via Likert scale 1-10.
A higher score indicates higher level of anxiety.
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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.
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Iowa Satisfaction with Anesthesia Scale (ISAS)
기간: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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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.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Time for Neuraxial Placement
기간: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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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.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Heart Rate
기간: 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.
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The patient's heart rate (HR) will be assessed.
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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.
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Mean Blood Pressure
기간: 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.
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The patient's mean blood pressure (MBP) will be assessed.
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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.
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Respiratory Rate
기간: 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.
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The patient's respiratory rate (RR) will be assessed.
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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.
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Oxygen Saturation
기간: 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.
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The patient's oxygen saturation (SpO2) will be assessed.
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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.
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Number of participants who experienced hypoxia
기간: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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The presence of hypoxia will be accessed.
Hypoxia will be defined as oxygen saturation (SpO2) < 90%.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Number of participants who experienced hypotension
기간: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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The presence of hypotension will be accessed.
Hypotension is systolic blood pressure (SBP) < 80% of baseline.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Number of participants who experienced tachycardia
기간: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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The presence of tachycardia will be accessed.
Tachycardia will be heart rate (HR) > 100 bpm.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Number of participants who experienced bradycardia
기간: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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The presence of bradycardia will be accessed.
Bradycardia will be heart rate (HR) < 60 bpm.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Number of participants who used vasoactive drugs (ephedrine, phenylephrine)
기간: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Vasoactive drugs (ephedrine, phenylephrine) are used if a patient has hypotension refractory to the standard care of fluids and prophylactic phenylephrine.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Number of participants who needed flumazenil
기간: From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Flumazenil is a reversal agent for remimazolam and used if the patient is clinically oversedated.
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From the initiation of study drug administration until participant discharge from the Post-Anesthesia Care Unit (PACU), up to approximately 4 hours post-delivery.
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Number of fetal NICU admissions
기간: Up to approximately 4 hours post-delivery.
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The number of fetal NICU admissions will be recorded.
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Up to approximately 4 hours post-delivery.
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Fetal APGAR scores
기간: 1 minute and 5 minutes after infant birth.
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The APGAR score is a cumulative score ranging from 0 to 10.
A higher score indicates a better health outcome.
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1 minute and 5 minutes after infant birth.
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Umbilical artery/vein pH
기간: Up to approximately 4 hours post-delivery.
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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.
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Up to approximately 4 hours post-delivery.
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Base excess
기간: Up to approximately 4 hours post-delivery.
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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.
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Up to approximately 4 hours post-delivery.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Benjamin Hyers, MD, Icahn School of Medicine at Mount Sinai Department of Anesthesiology, Perioperative, and Pain Medicine
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 11월 25일
기본 완료 (추정된)
2028년 5월 1일
연구 완료 (추정된)
2028년 5월 1일
연구 등록 날짜
최초 제출
2026년 6월 11일
QC 기준을 충족하는 최초 제출
2026년 6월 11일
처음 게시됨 (실제)
2026년 6월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 8일
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY-26-00500
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .