Low Dose Hyperbaric Bupivacaine and Dexmedetomidine as an Adjuvant, Caesarean Section: Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Haemodynamic stability and total doses of IV fluids and vasopressors
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of low dose scheme with dexmedetomidine as an adjuvant. Taking in consideration optimum intraoperative surgical conditions, best post-operative pain free experience, and more stable hemodynamic.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Full-term pregnant women
- •Singleton gestation
- •American Society of Anaesthesiologists (ASA) physical status classes II and I
排除标准
- •Preterm pregnancy (<37 wks. gestation)
- •Multiple gestation
- •Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medications
- •Asthma and allergy to non-steroidal anti-inflammatory drugs
- •Conditions that prevent spinal anaesthesia
- •Failed spinal block and conversion to general anaesthesia
- •A history of established chronic pain
- •Drug addiction
- •A psychiatric disorder
- •Inability to communicate effectively
研究组 & 干预措施
LD-DEX
This group will receive 7mg hyperbaric bupivacaine (about 1.4 ml of hyperbaric bupivacaine 0.5%) and 10μg dexmedetomidine (10 unit by U-100 insulin syringe using a preservative free dexmedetomidine 100μg/ml).
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Haemodynamic stability and total doses of IV fluids and vasopressors
时间窗: Intraoperative
Density of motor and sensory blockade
时间窗: Intraoperative
Time to first postoperative rescue analgesic request
时间窗: 24 hour
次要结局
- Hospital in stay(24 hour)
- The peak sensory level of block(Intraoperative)
- Time from intrathecal injection to peak sensory block level(Intraoperative)
- The intraoperative patient and surgeon satisfaction (successful delivery)(Intraoperative)
- The time to two sensory block segment regression(Intraoperative and 24 hour)
- Degree and duration of motor block(Intraoperative and 24 hour)
- Postoperative pain scores for 24 hours(24 hour)
- Intraoperative and postoperative sedation scores(Intraoperative and 24 hour)
- Intraoperative analgesic supplementation during operation(Intraoperative)
- Incidence of side effects: nausea, vomiting, shivering, pruritus, respiratory depression, and desaturation.(Intraoperative and 24 hour)
- Frequency and total dose of postoperative analgesics(24 hour)
- Time to S1 level sensory regression(Intraoperative and 24 hour)
研究者
Ahmed Ashraf Nasr
Assisstant Lecturer Anesthesia, Intensive care and Pain management - Faculty of Medicie - Menoufia University
Menoufia University