Comparison of Clinical Effects of Meperidine and Sufentanil Added to 0.5% Hyperbaric Bupivacaine for Spinal Anesthesia in Patients Undergoing Cesarean Section
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- First analgesic request time
研究概览
简要总结
Subarachnoid block is a widely used anesthetic technique for cesarean section. To improve the quality of analgesia and prolong its duration, the addition of intrathecal opioids to local anesthetics has been encouraged.
In a double blind randomized controlled trial, 60 parturient women ASA 2-3 scheduled for elective cesarean delivery under spinal anesthesia will be randomly divided into 2 groups: Group 1 will receive sufentanil 5 μg and Group 2 will receive meperidine 12.5 mg. In every group, 0.5% heavy bupivacaine 10 will be added.
详细描述
A questionnaire will be used to collect data. Patients' demographic and operative characteristics will be recorded. These include block level, heart rate, mean arterial pressure, nausea, vomiting, shivering and use of vasopressors. Post-operative data include pain, analgesic consumption, nausea and vomiting, as well as patients and surgeons satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant women with American Society of Anesthesiologist (ASA) 2-3
- •scheduled for elective cesarean section.
排除标准
- •refuse to participate in the study,
- •requiring emergency obstetric care,
- •ASA IV or V,
- •having systemic diseases,
- •a known fetal anomaly,
- •placenta previa,
- •abruption placenta
- •with a history of hypersensitivity or allergy to any of the study drugs,
- •operation time longer than 1.5 hour,
- •blood loss more than 1500 millilitres,
- •those with any contraindication to the technique proposed,
研究组 & 干预措施
Sufentanil Group
Patients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia
干预措施: sufentanil (Drug)
Sufentanil Group
Patients will receive sufentanil 5 μg in addition to 0.5% heavy bupivacaine spinal anesthesia
干预措施: Bupivacaine (Drug)
Meperidine Group
Patients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia
干预措施: meperidine (Drug)
Meperidine Group
Patients will receive meperidine 12.5 mg in addition to 0.5% heavy bupivacaine spinal anesthesia
干预措施: Bupivacaine (Drug)
结局指标
主要结局
First analgesic request time
时间窗: 24 hours post operatively
The duration of effective analgesia is defined as the time from intrathecal injection to first patient analgesic demand
次要结局
- Analgesic requirements(24 hours post operatively)
研究者
Saleh Kanawati
Acting chairperson
Makassed General Hospital