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Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery

2026年4月30日 更新者：Ruth Landau-Cahana、Columbia University
This study will examine whether addition of dexmedetomidine or clonidine (two alpha-2 adrenergic agonists) will improve the comfort of patients during spinal anesthesia for cesarean delivery. When added to standard spinal anesthesia consisting of bupivacaine (a local anesthetic) and fentanyl and morphine (two opioids), these medications may decrease some of the pulling/tugging/pressure sensations that patients sometimes feel during cesarean delivery, may prolong the anesthetic time, and may decrease postoperative pain.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

While spinal anesthesia almost always creates a reasonably comfortable operative/birth experience, a significant proportion of women do experience significance "pressure" or "pulling" and some do have sensations described as painful during the operation. This has received increased interest in both the medical and lay press in recent years. The main medication in a spinal anesthetic is the local anesthetic, usually bupivacaine, but a variety of adjuvants can and are used to improve the analgesia and decrease sensation (or increase the time period of effectiveness) of the anesthetic. Opioids (usually fentanyl or sufentanil for intraoperative benefits and morphine for postoperative analgesia) are very commonly added to spinal anesthetics for cesarean delivery in the United States.

Somewhat less commonly, but increasingly, alpha-2 adrenergic agonists (clonidine or dexmedetomidine), which have sedative and analgesic properties (mostly analgesic when given into spinal fluid) are added in an attempt to improve the intraoperative experience and/or lengthen the time the block is effective. These adjuvants, although not approved specifically for this use in spinal anesthesia, have become more widely used in spinal anesthesia, including for cesarean delivery, and have been mentioned/recommended in recent statements by the American Society of Anesthesiologists for use when additional or improved analgesia may be needed or desired.

The quality of the studies of intrathecal dexmedetomidine as part of spinal anesthesia for cesarean delivery is quite poor. This study will investigate whether clonidine or dexmedetomidine, when added to a spinal anesthetic containing bupivacaine/fentanyl/morphine, will improve intraoperative analgesia/anesthesia, decrease unwanted sensation, and assess what the other effects will be (prolongation of sensory and motor block, effects on blood pressure, other side effects).

研究类型

介入性

注册 (估计的)

150

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • New York
      • New York、New York、美国、10032
        • Columbia University Irving Medical Center/NewYork Presbyterian Hospital
        • 首席研究员：
          • Ruth Landau, MD
        • 接触：
        • 接触：
        • 副研究员：
          • Richard M Smiley, MD, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Pregnant women undergoing cesarean delivery with spinal anesthesia

Exclusion Criteria:

  • Significant cardiovascular, psychiatric or respiratory disease
  • using opioids or with chronic pain syndrome
  • Multiple gestation
  • BMI >40 kg/m2
  • Quaternary or greater cesarean
  • < 37 weeks gestation
  • Non-English or Spanish speaking
  • planned vertical skin incision
  • planned vertical (classical) uterine incision
  • allergy to clonidine, dexmedetomidine or other study drug

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：阶乘赋值
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Clonidine
Participants will receive 30 mcg clonidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).
药品：Clonidine
30 mcg Clonidine will be given by intrathecal administration
实验性的：Dexmedetomidine
Participants will receive 4 mcg dexmedetomidine in addition to the standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).
药品：Dexmedetomidine
4 mcg Dexmedetomidine will be given by intrathecal administration
其他名称：
  • 前序
无干预：Control
Participants will receive standard spinal anesthetics (12 mg bupivacaine, 15 mcg fentanyl, 150 mcg morphine).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of intraoperative discomfort
大体时间：during cesarean surgery

The primary outcome of this study is the incidence of self-reported intraoperative discomfort, defined as pain or uncomfortable pressure, tugging, pulling feeling during cesarean delivery.

At specific timepoints during cesarean delivery surgery, the patient will be asked "Do you feel uncomfortable sensations (pain, pressure, pulling, tugging)?" If the answer is "yes, " she will be asked "Do you want medication to treat it?"

The timepoints specified will be:

  1. Foley (urinary) catheter placement
  2. Allis clamp test (testing for pain at incision site and umbilicus before starting surgery)
  3. Skin incision
  4. Uterine incision
  5. Delivery
  6. Uterine exteriorization
  7. Fascial closure
  8. Skin closure
  9. Manual uterine compression in OR after closure
  10. At any point other than the above that the patient complains of pain or uncomfortable sensations
during cesarean surgery

次要结果测量

结果测量
措施说明
大体时间
Obstetric Quality of Recovery (ObsQoR-10) Score
大体时间：0-6, 6-12, 12-24, 24-48 hours after surgery
Postoperative pain will be assessed by the self-reported Obstetric Quality of Recovery Score after surgery. The full scale is 0 to 10, with 0 being no pain, and 10 being the worst pain imaginable.
0-6, 6-12, 12-24, 24-48 hours after surgery
Length of motor and sensory block
大体时间：2-5 hours
How long form spinal injection to regaining ability to bend knees and feel sensation in lumbar area
2-5 hours
Incidence of Hypotension
大体时间：first 20 minutes after spinal, or until delivery
1. Decrease in baseline systolic blood pressure greater than 20%, or to less than 90 mm HG
first 20 minutes after spinal, or until delivery
Phenylephrine use
大体时间：20 minutes
Total phenylephrine infusion given over first 20 minutes after spinal (or until delivery).
20 minutes
PACU side-effects/events
大体时间：2-3 hours postop

Events in the post-anesthesia care unit:

  1. Hypotension requiring treatment
  2. Nausea/vomiting
  3. Shivering
  4. Sedation
2-3 hours postop
Blood pressure
大体时间：~ 20 minutes from spinal injection
Systolic and diastolic blood pressure every minute from spinal injection for 20 minutes or until delivery (whichever comes first)
~ 20 minutes from spinal injection
Additional vasopressor use
大体时间：From Spinal anesthesia to 20 minutes or delivery (whichever comes first)
Any phenylephrine, ephedrine or epineprhine given other than phenylephrine infusion
From Spinal anesthesia to 20 minutes or delivery (whichever comes first)

其他结果措施

结果测量
措施说明
大体时间
Numerical reading on PMD-200
大体时间：1-2 hours (intraoperatve)

Reading on the PMD (an FDA-approved device that uses a finger probe to detect "nociception," " a measure of sensation/discomfort/pain. The readngs will be recorded at the following timepoints:

  1. Skin incision
  2. Delivery
  3. 10 min post delivery/uterine exteriorization
  4. Uterine re-insertion into the abdomen
  5. Skin closure
1-2 hours (intraoperatve)
Opioid use postoperatively
大体时间：48 hours
Milligram morphine equivalents used over 48 hours postop
48 hours
Side effects
大体时间：48 hours postop
nausea/vomiting, itching
48 hours postop
UA and UV blood gases
大体时间：at delivery
Umbilical artery and vein blood gases at birth
at delivery
Need for neonatal resuscitation
大体时间：birth to 2 hours
need for care beyond routine neonatal care
birth to 2 hours
Heart rate (pulse)
大体时间：Spinal injection to 20 min later or delivery (~20 min)
2. Heart rate every minute from spinal injection for 20 minutes or until delivery (whichever is first)
Spinal injection to 20 min later or delivery (~20 min)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Columbia University

调查人员

  • 首席研究员：Ruth Landau, MD、Columbia University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2028年5月1日

研究注册日期

首次提交

2026年1月8日

首先提交符合 QC 标准的

2026年4月30日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年5月5日

上次提交的符合 QC 标准的更新

2026年4月30日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ACYY0438

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Based on an appropriate request form qualified researchers, we are willing to share de-identified data regarding participants in spreadsheet or other appropriate form , if allowed by our local IRB.

IPD 共享访问标准

Upon request

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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