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临床试验/NCT04174872
NCT04174872已完成4 期

A Comparative Study Between Dexmedetomidine and Midazolam as Adjuvant to Bupivacaine During Epidural Anesthesia For Elective Gynecological Operations

Cairo University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
150
试验地点
1
主要终点
Onset of sensory blockade

研究概览

简要总结

Regional anesthesia is the preferred mode of anesthesia for major abdominal surgeries in present times. Gynecological surgeries are often associated with severe pain requiring a well-planned analgesia regimen to ensure adequate patient-comfort, early mobilization, and to decrease stay time in the hospital/post-anesthesia care unit (PACU) enabling patients to return to their normal activities quicker. Dexmedetomidine has been approved by Food and Drug Administration (FDA) as a short-term sedative for mechanically ventilated intensive care unit (ICU) patients as it has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. Epidural administration of preservative free midazolam induces antinociceptive effects in humans, when midazolam is added it acts through gamma amino-butyric acid (GABA) receptors and enhances the affinity of GABA receptors. Midazolam is involved in the release of endogenous opioids acting on spinal delta receptors so antinociceptive effects of morphine like substances are potentiated when epidural midazolam is added. Studies have revealed that use of epidural midazolam provides effective analgesia in adults. So, the present study will evaluate the additive analgesic effects of epidural midazolam in combination with bupivacaine in elective gynecologic surgeries and compare the results with the use of bupivacaine with dexmedetomidine and observe the quality of epidural anesthesia with occurrence of side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients of ASA I-II.
  • Aged 18-55 years undergoing elective gynecological surgeries

排除标准

  • Patient refusal.
  • Patients with history of diabetes mellitus, cardiac disease, hypertension, chronic obstructive respiratory disease, coagulation abnormalities, spinal deformities, patients allergic to amide type of local anesthetics, localized skin sepsis, neurological disease, hepatic and renal diseases, peripheral neuropathy and psychiatric diseases.

研究组 & 干预措施

Dexmedetomidine

Other

It has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. It is now being used as a neuraxial adjuvant that can be used as an effective adjuvant in epidural anaesthesia as it intensifys the motor block and prolongs the duration of postoperative analgesia.

干预措施: Dexmedetomidine (Drug)

Dexmedetomidine

Other

It has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. It is now being used as a neuraxial adjuvant that can be used as an effective adjuvant in epidural anaesthesia as it intensifys the motor block and prolongs the duration of postoperative analgesia.

干预措施: Midazolam (Drug)

Midazolam

Other

Midazolam has been reported to have a spinally mediated analgesic effect. Clinically, single-shot epidural or spinal administration of midazolam has been shown to have an analgesic effect on perioperative pain.

干预措施: Dexmedetomidine (Drug)

Midazolam

Other

Midazolam has been reported to have a spinally mediated analgesic effect. Clinically, single-shot epidural or spinal administration of midazolam has been shown to have an analgesic effect on perioperative pain.

干预措施: Midazolam (Drug)

结局指标

主要结局

Onset of sensory blockade

时间窗: Eight months

time interval from epidural injection of drugs to sensory blockade at T10

次要结局

未报告次要终点

研究者

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

Reham Ali Abdelhaleem Abdelrahman

Lecturer of Anesthesia

Cairo University

研究点 (1)

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