Can Subarachnoid Dexmedetomidine Decrease the Incidence of Postoperative Nausea and Vomiting and Shivering With Minimal Hemodynamic Instability in CS?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effect of subarachnoid dexmedetomidine on hemodynamic parameters.
研究概览
简要总结
Background: Highly selective α-2 agonist dexmedetomidine in increasingly used as an intrathecal adjuvant for caesarean section performed under subarachnoid block.
Aim of the Study: The aim of the study is to determine whether low dose dexmedetomidine added to local anesthetic for spinal anesthesia will attenuate perioperative nausea and vomiting and shivering in lower segment caesarean section (LSCS) with minimal hemodynamic instability or not.
Patients and Methods: Sixty parturients planned for elective CSs under spinal anesthesia were enrolled in this prospective controlled study and randomly divided into two equal groups. Spinal block was achieved with 10mg hyperbaric bupivacaine 0.5% plus 5µg dexmedetomidine (group D) (dexmedetomidine group) or 0.2 ml normal saline (group C) (control group). Hemodynamic parameters, incidence of nausea and vomiting and shivering were recorded.
Keywords: Dexmedetomidine, Cesarean Section, Bupivacaine, Spinal Anesthesia, Shivering, PONV
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Medically free pregnant Female from 18 to 30 yrs old.
- •Undergoing elective LSCS.
- •Body mass index less than
- •Consenting for sub arachnoid anesthesia.
- •Coagulation profile is within normal ranges.
排除标准
- •Emergency LSCS.
- •Patient refusal enrollment in the study.
- •Allergy to the medications.
- •Coagulopathy or anticoagulation drugs.
- •Fetal or Maternal comorbidities.
研究组 & 干预措施
Study drug (dexmedetomidine intrathecal)
5 mcg dexmedetomidine intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
Control (saline)
0.2 ml normal saline intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
结局指标
主要结局
Effect of subarachnoid dexmedetomidine on hemodynamic parameters.
时间窗: Two hours
Measure heart rate, blood pressure, temperature, oxygen saturation
次要结局
- Effect of subarachnoid dexmedetomidine on incidence of postoperative nausea and vomiting (PONV) and shivering.(Six hours)
研究者
Shaimaa Mohamed Samir Ezzat Rakhia
MD
Ain Shams University