INTRAVENOUS Versus EPIDURAL DEXMEDETOMIDINE for ANALGESIA in NORMAL VAGINAL DELIVERY: A RANDOMIZED CONTROLED STUDY
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- pain relief
研究概览
简要总结
compare the effect of intravenous and epidural dexmetomidine as an adjuvant to local anesthetics in epidural labor analgesia in normal labor
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Full term (≥ 37 weeks) healthy primigravida parturients ASA2
- •with single fetus scheduled for vaginal delivery
- •with cephalic presentation
- •requesting labor analgesia.
排除标准
- •Allergy to dexmetomidine.(based on previous history)
- •Cardiac conduction abnormalities.(all degrees of heart block , tachyarrythmias)
- •Malpresentation.
- •Preeclampsia or gestational hypertension
- •Uncontrolled diabetes HBA1c ≥ 6.5%
- •Uncontrolled renal failure
- •Uncontrolled liver disease
- •Bleeding tendency or coagulopathy.
- •Contraindication or patient refusal to epidural block.
- •Body mass index ≥ 35.
研究组 & 干预措施
plan group
bupivacaine will be administered epidurally as a loading dose then epidural continuous infusion with 0.125 % bupivacaine at rate 10 ml will be a maintainance for analgesia .IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml \hr.
干预措施: Bupivacaine Injection (Drug)
epidural group
10 ml of 0.125 % buoivacaine with 0.5 µg\ml dexmetomidine as a loading dose then continuous epidural infusion of 0.125% bupivacaine with 0.5µ/ml dexmetomidine at a rate of 10 ml\hr will be used as maintainance . IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml\hr
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
epidural group
10 ml of 0.125 % buoivacaine with 0.5 µg\ml dexmetomidine as a loading dose then continuous epidural infusion of 0.125% bupivacaine with 0.5µ/ml dexmetomidine at a rate of 10 ml\hr will be used as maintainance . IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml\hr
干预措施: Bupivacaine Injection (Drug)
intravenous group
continuous intravenous dexmetomidine infusion at rate of 0.5 µg / kg / hour in addition to same epidural infusion of 0.125% bupivacaine
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
intravenous group
continuous intravenous dexmetomidine infusion at rate of 0.5 µg / kg / hour in addition to same epidural infusion of 0.125% bupivacaine
干预措施: Bupivacaine Injection (Drug)
结局指标
主要结局
pain relief
时间窗: on delivery
VAS score from 0 to 10
次要结局
未报告次要终点
研究者
mostafa saieed fahim mansour
lecturer
Menoufia University