Intrathecal Dexmedetomidine Versus Fentanyl With Bupivacaine for Postoperative Analgesia in Children Undergoing Major Abdominal Cancer Surgery
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain by Face, Legs, Activity, Crying, and Consolability (FLACC) Pain Score
研究概览
简要总结
In this study the investigators aim to determine the analgesic effect and side effects of intrathecal fentanyl and dexmedetomidine as adjuvant to local anesthetics in pediatric patients undergoing major abdominal cancer surgeries.
详细描述
After obtaining approval of the local ethics committee of South Egypt Cancer Institute, Assiut University, Assiut, Egypt, and parent's written informed consent, a randomized double -blinded prospective study will be conducted on (60) pediatric patients.
After applying standard monitors; Pulse oximetry (Spo2), Noninvasive arterial blood pressure, Electrocardiography (ECG), pre-medication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam (0.01 mg/kg), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask and neuromuscular blockade (atracurium besylate 0.5mg/kg) will be used to facilitate endotracheal intubation. After that an intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery.
After securing the tube in place, patients will be placed in lateral decubitus position and intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany).
Children will be randomly allocated into 3 groups by using opaque sealed envelopes containing a computer generated randomization schedule. The opaque sealed envelopes are sequentially numbered that will be opened before application of anesthetic plan and each group will include (20) patients:
Group (1): children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg in 2ml volume; it will be injected slowly.
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 (Participant, Investigator)
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
- •American Society of Anesthesiologists (ASA) physical status I and II
- •Patients scheduled for major abdominal cancer surgeries, expected to last more than 90 minutes
排除标准
- •Sacral bone abnormalities
- •Spina bifida
- •Coagulopathy
- •Mental delay or retardation
- •Known allergy to the study drugs
- •Local infection at the site of injection
研究组 & 干预措施
fentanyl and dexmedetomidine
intrathecal bupivacaine (0.5%) 0.4mg/kg plus fentanyl and dexmedetomidine in 2ml volume will be injected slowly over 20 seconds.
干预措施: Bupivacaine (Drug)
dexmedetomidine and placebo for fentanyl
intrathecal bupivacaine (0.5%) 0.4mg/kg plus dexmedetomidine 0.2 μg/kg in 2ml volume and placebo (for fentanyl 0.2 μg/kg) it will be injected slowly over 20 seconds.
干预措施: Bupivacaine (Drug)
dexmedetomidine and placebo for fentanyl
intrathecal bupivacaine (0.5%) 0.4mg/kg plus dexmedetomidine 0.2 μg/kg in 2ml volume and placebo (for fentanyl 0.2 μg/kg) it will be injected slowly over 20 seconds.
干预措施: Dexmedetomidine (Drug)
fentanyl and placebo for dexmedetomidine
intrathecal bupivacaine (0.5%) 0.4mg/kg plus fentanyl 0.2 μg/kg in 2ml volume and placebo (for dexmedetomidine 0.2 μg/kg) it will be injected slowly over 20 seconds.
干预措施: Bupivacaine (Drug)
fentanyl and placebo for dexmedetomidine
intrathecal bupivacaine (0.5%) 0.4mg/kg plus fentanyl 0.2 μg/kg in 2ml volume and placebo (for dexmedetomidine 0.2 μg/kg) it will be injected slowly over 20 seconds.
干预措施: Fentanyl (Drug)
结局指标
主要结局
Pain by Face, Legs, Activity, Crying, and Consolability (FLACC) Pain Score
时间窗: one day
FLA CC pain score will be assessed immediately postoperative and then every 2 hours. Each item is scored 0 to 2, yielding a total between 0 and10
次要结局
- Recurrence of pain(24 hours)
研究者
Rania Mohammed Abd elemam
Director, Clinical Research
South Egypt Cancer Institute