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临床试验/NCT06917898
NCT06917898进行中(未招募)1 期

Fentanyl Versus Midazolam During Spinal Block With Bupivacaine for Elective Cesarean Delivery: a Prospective Randomized Double-blind Clinical Trial.

Makassed General Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年4月1日最近更新:
干预措施

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
80
试验地点
1
主要终点
rescue analgesia

研究概览

简要总结

It is well documented in the practice of anesthesia the effectiveness of bupivacaine when added with other adjuvants including midazolam, opioids, and ketamine during neuraxial spinal block for cesarean delivery, however comparison of the superiority of midazolam 2mg over fentanyl 25 micrograms or vice versa with bupivacaine during cesarean delivery has not been established and if performed diligently, could potentially change our understanding and current practice for better patient outcomes.

详细描述

A study published on Jan - Feb 2024 has compared adjuvants fentanyl 25 micrograms and midazolam 2mg when added to Levobupivacaine for patients undergoing cesarean section with Midazolam being the superior drug of choice with less side effects. [1] Another study done around our locality at the American University of Beirut compared the postoperative analgesic effect of ketamine and fentanyl when added to bupivacaine in patients undergoing cesarean section with results conclusive of equally effective post cesarean pain control. [2] One study compared intrathecal midazolam 2mg with intrathecal fentanyl 12.5 micrograms with bupivacaine [3], and results elucidated equal surgical analgesia during the operation in contrast to the superior Midazolam 2mg vs the intrathecal fentanyl 25 micrograms when added to levobupivacaine mentioned in the first study. Current literature is void of studies comparing intrathecal fentanyl 25 micrograms vs intrathecal midazolam 2mg when added to bupivacaine for cesarean delivery.

Study objectives:

Comparative studies are available for different adjuvants when administered along with bupivacaine or levobupivacaine, but the specific aim and target of this study is to compare Hyperbaric Bupivacaine 0.5% 12.5 mg with fentanyl 25 micrograms (2 ml) versus Hyperbaric Bupivacaine 0.5% 12.5 mg with midazolam 2mg (2 ml) for cesarean delivery.

Levobupivacaine is not as readily available as bupivacaine in our population. Opioids have significantly more side effects when administered intrathecally including pruritus, respiratory depression, post operatively nausea and vomiting, and any attempt to decrease their usage to improve patient satisfaction without compromising the overall analgesic effect should be pursued. The results from this study could potentially change current practice in our hospital and across local and national areas respectively.

This study aims to provide conclusive data about the superiority of midazolam in reduction of postoperative pain, reduction of postoperative rescue analgesia, the quality of sensory block, and the reduction in side effects when administered with Bupivacaine as opposed to Levobupivacaine which was demonstrated in the study [1] mentioned above.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients aged 18-45 with American Society of Anesthesia (ASA) class II will be included in the study.

排除标准

  • patients with history of opioid substance abuse
  • pre-eclampsia or eclampsia
  • Gestational Hypertension
  • uncontrolled diabetes mellitus
  • significant cardiac, renal, and hepatic morbidity (i.e., ASA class III patients).

研究组 & 干预措施

Intrathecal Fentanyl

Active Comparator

干预措施: Spinal Anesthesia with Bupivacaine and Fentanyl (Drug)

Intrathecal Midazolam

Active Comparator

干预措施: Spinal Anesthesia with Bupivacaine and Midazolam (Drug)

结局指标

主要结局

rescue analgesia

时间窗: 24 Hours

The primary outcome is the timing of the first analgesia requested postoperatively (i.e., the rescue analgesia).

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

Omar Rajab

Chairman of Anesthesia Department

Makassed General Hospital

研究点 (1)

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