Evaluation of the Intraoperative and PO Analgesic Outcome of Using Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The level of Post operative sedation
研究概览
简要总结
The study will be carried on children undergoing lower abdominal surgeries. Patients will be randomly categorized into two study groups. Group A will include patients who will receive bupivacaine intrathecal injection without adjuvant. Group B will include patients who will receive bupivacaine and preservative-free midazolam.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children aged 3-12 years, assigned for lower abdominal and pelvic surgeries and will be ASA grade I after obtaining written fully informed parental consent.
排除标准
- •Patients with congenital anomalies especially of the spine, infections in the skin of the back, had coagulopathy, or allergy to the study drugs and those whose parents refused to give the consent .
研究组 & 干预措施
Group A
Will include patients who will receive bupivacaine intrathecal injection without adjuvant.
干预措施: intrathecal bupivacaine (Drug)
Group B
Will include patients who will receive bupivacaine and midazolam.
干预措施: intrathecal bupivacaine (Drug)
Group B
Will include patients who will receive bupivacaine and midazolam.
干预措施: midazolam (Drug)
结局指标
主要结局
The level of Post operative sedation
时间窗: 90 days
will be assessed at 30 \& 120 minutes after admission to the recovery room using the modified WilsonSedation Score (WSS)
PO hospital stay
时间窗: 90 days
Duration of PO hospital stay
Duration of postoperative analgesia
时间窗: 90 days
Efficacy of PO analgesia will be determined, by an assistant who will be blinded about the using the observational pain-discomfort scale (OPS), which assesses behavioral parameters that can be evaluated objectively.
Duration of analgesia
时间窗: 90 days
defined as the time elapsed since end of the surgical procedure till OPS reaches \>11
Post operative resolution of motor block
时间窗: 90 days
will be assessed using Bromage score till complete recovery.
次要结局
- The rate of procedural success(90 days)
研究者
MOHAMMED FAWZI ALI ABOSAMAK
consultant anesthesia
Tanta University