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临床试验/NCT02951806
NCT02951806已完成不适用

Effect of Slow Injection of Fentanyl on the Incidence of Spinal Anesthesia Induced Itching in Cesarean Section

Dr. Soliman Fakeeh Hospital0 个研究点目标入组 215 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
215
主要终点
( 0 - 10) Itching scale

研究概览

简要总结

Pruritus is a troublesome side-effect of neuraxial (epidural and intrathecal) opioids. Sometimes it may be more unpleasant than pain itself. The incidence of pruritus is 83% in postpartum patients and 69% in non-pregnant patients including males and females (1). Some researchers concluded that slow injection rate of hyperbaric bupivacaine may be a simple and effective way to reduce the incidence and severity of hypotension during cesarean section under spinal anesthesia (2). In this new research I want to investigate the effect of slow injection of fentanyl separately, in spinal anesthesia for cesarean section, on the incidence of itching In this double blind randomized study two hundred parturient will be randomly allocated in to two groups; Group (R) will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds. Group (S) will receive the same dose in 90 seconds All parturient will receive 10 mg bupivacaine in 45 min after fentanyl. Exclusion criteria will be those with allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.

Parturient will be monitored regarding the incidence of itching, hypotension, nausea and vomiting. Onset and level of sensory block will also be recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Elective and emergency cesarean section parturient.

排除标准

  • Allergy to any medications, contraindications to spinal anesthesia, those who requested sedation, presence of skin lesions that may cause itching and opioid addiction.

研究组 & 干预措施

(R) Rapid spinal fentanyl injection

Active Comparator

Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 15 seconds then 10 mg hyperbaric bupivacaine.

干预措施: (R) Rapid spinal fentanyl injection (Drug)

(S) Slow spinal fentanyl injection

Active Comparator

Patients will receive 25 mic fentanyl spinal ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.

干预措施: (S) Slow spinal fentanyl injection (Drug)

结局指标

主要结局

( 0 - 10) Itching scale

时间窗: 60 min

次要结局

  • Satisfactory Block ( no pain, Pain relieved by opioids or pain needs general anesthesia(60 min)

研究者

发起方
Dr. Soliman Fakeeh Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Amr Aly Ismail Keera

Prof. Amr Aly Keera

Dr. Soliman Fakeeh Hospital

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