NCT03018301Unknown2 期
Effect of Single Intravenous Ketamine Dose on Postoperative Pain Following Cesarean Section Under Spinal Anesthesia: A Randomized Control Clinical Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- • Number of Subjects Requiring Supplemental Analgesia
研究概览
简要总结
The purpose of this study is to investigate the analgesic effect of low-dose intravenous ketamine in pregnant mothers undergoing cesarean section under Bupivacaine spinal anesthesia.
详细描述
- No premedication will be given, and patients will be monitored by electrocardiogram, non-invasive arterial blood pressure, and pulse oximetry when they entered the operating room.
- 18 gauge IV cannula will be inserted and all patients will be preloaded with 10 ml/kg of lactate ringer over 20 min period.
- All participants will have spinal anesthesia using bupivacaine. The dose of the drug, as well as the method of injection will be identical for all individuals; 10 mg (2 cc 0.5%), in the L4-L5 space using needle 25 G, midline, with the patient in a sitting position.
- After administering bupivacaine, and prior to surgery the height of the sensory block will be assessed bilaterally (complete loss of sensation to ice) in a ascending fashion starting from T12 dermatome.
- Once adequate anesthesia to at least T6 dermatome will be achieved, the operation will be allowed to begin. When systolic blood pressure decrease to < 90 mmHg, or 30% of the pre-anesthetic blood pressure, it will be corrected by administering 5 mg ephedrine.
- Patients will be asked to report any intraoperative pain using visual pain score(VPS)of 0(no pain) 10(worst pain).
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
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Eligible women ASA class 1 and 2, are at term (≥37 week gestation), Scheduled for elective cesarean section whose anesthetic plan is for spinal anesthesia with Bupivacaine and intravenous pethidine and paracetamol for post operative analgesia.
排除标准
- •• Body mass index ≥40 kg/m2,
- •Known allergy to any of the study medications,
- •Contraindication to the spinal anesthesia,
- •History of substance abuse,
- •History of hallucinations,
- •Chronic opioid therapy,
- •Chronic pain.
研究组 & 干预措施
Ketamine group
Active Comparator
will receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.
干预措施: Ketamine (Drug)
Control group
Placebo Comparator
will receive intravenous 20 ml of normal saline, delivered over 10 minutes.
干预措施: Normal saline (Other)
结局指标
主要结局
• Number of Subjects Requiring Supplemental Analgesia
时间窗: 24 hours postoperative
次要结局
- Cumulative morphine/paracetamol(24 hours postoperative)
- Number of subjects reporting nausea, vomiting(24 hours postoperative)
研究者
Abdelrady S Ibrahim, MD
Assistant professor of anesthesia and ICU
Assiut University
研究点 (1)
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