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临床试验/NCT07506044
NCT07506044招募中不适用

The Effect of Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine for Parturients Having Dural Puncture Epidural Technique to Elaborate Labor Pain

Menoufia University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2026年5月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
2

研究概览

简要总结

The study aimed to determine the effects of using varied doses of DEX on the concentration of bupivacaine injected for epidural labor analgesia, and to assess the benefits of the dural puncture epidural.

详细描述

The primary efficacy point is the total dose of bupivacaine administered during labor. The secondary endpoints include the VAS pain scores, number of administered additional doses, incidence of motor block, delivery type (spontaneous vaginal or cesarean), maternal satisfaction, and complications such as hypotension, fetal bradycardia, and epidural-related maternal fever.

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, Care Provider)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women who attend the Emergency Department in labor, with cervical dilation of 3-5 cm,
  • normally presented singleton fetus, intact fetal membranes, and who are free of

排除标准

  • Exclusion Criteria:
  • Abnormal fetal presentation or lie, 'premature rupture of membranes, maternal fever, fetal distress, pregnancy-induced diseases
  • abnormal placental position,
  • ASA grade>II
  • marked obesity,
  • allergy or contraindications to the used drugs,
  • spinal deformity or disorders 'cutaneous diseases or infection at the injection site

研究组 & 干预措施

Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 )

Active Comparator

Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.4

干预措施: Dexmedetomidine 0.4 added (Drug)

Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 )

Active Comparator

Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.6

干预措施: Epidural Catheter with bupivacaine (Device)

Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 )

Active Comparator

Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.6

干预措施: Epidural with dural puncture (Device)

Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 )

Active Comparator

Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.6

干预措施: Dexmedetomidine 0.6 added (Drug)

Epidural group with bupivacaine CE

Active Comparator

Epidural with plain bupivacaine DPE

干预措施: Epidural Catheter with bupivacaine (Device)

Epidural puncture with bupivacaine

Active Comparator

Combined epidural with epidural puncture using bupivacaine

干预措施: Epidural Catheter with bupivacaine (Device)

Epidural puncture with bupivacaine

Active Comparator

Combined epidural with epidural puncture using bupivacaine

干预措施: Epidural with dural puncture (Device)

Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 )

Active Comparator

Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.4

干预措施: Epidural Catheter with bupivacaine (Device)

Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 )

Active Comparator

Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.4

干预措施: Epidural with dural puncture (Device)

研究者

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

rabab Mohammad habeeb

Principle investigator

Menoufia University

研究点 (2)

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