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临床试验/NCT07567495
NCT07567495尚未招募4 期

Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery

Columbia University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
入组人数
150
试验地点
1

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women undergoing cesarean delivery with spinal anesthesia

排除标准

  • 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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruth Landau-Cahana

Virginia Apgar, M.D. Professor of Anesthesiology

Columbia University

研究点 (1)

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