Comparing the Synergistic Effect of Caudal Dexmedetomidine and Propofol Versus Caudal Dexmedetomidine Only or Propofol Only in Prevention of Sevoflurane Related Emergence Agitation in Pediatric Patients Undergoing Congenital Inguinal Hernia Repair: Randomized Double-blind Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- postoperative EA
研究概览
简要总结
evaluate the synergistic efficacy of propofol and caudal dexmedetomidine for postoperative EA in pediatrics aged from to 2 to 5 years maintained on sevoflurane inhalational anesthesia and scheduled for conginital inguinal hernia repair surgeries
详细描述
Eligibility and type of the study: This prospective randomized placebo-controlled double-blind study will be conducted after approval from the Institutional Ethics Committee and obtaining written informed consent from parents of children scheduled for conginital inguinal hernia repair procedures under general anesthesia. This study will be conducted at pediatric surgery operating theatre, Assiut University Hospitals.
Sample size:
Drugs coding and Randomization: Patients will be randomly allocated into three equal groups with the help of a computer-generated table of random numbers to receive the study drugs. One anesthesiologist, not involved in the study procedure or data collection, will prepare the study drugs in identical coded syringes. Access to these codes will be only available to one anesthesiologist who will prepare the syringes according to the study drugs used. To ensure double-blinding, the anesthetic technique and outcome data will be collected by an anesthesiologist not included in preparing study drugs or envelops coding. Also the parents will be blinded to the drug grouping of their children.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 2-7 years
- •Both genders
- •American society of anesthesiologists (ASA) physical state I-II
- •Children undergoing sub-umbilical abdominal surgeries
排除标准
- •Guardians refusal
- •Congenital anomalies at the lower spine or meninges
- •Increased intracranial pressure
- •Skin infection at the site of injection
- •Bleeding diathesis
- •Known allergy to any drugs used in this study
- •Children with behavioral changes; physical or developmental delay; neurological disorder or psychological disorder.
- •Children on sedative or anticonvulsant medication.
研究组 & 干预措施
Group A (propofol group)
30 patients will receive propofol 1mg/kg before the start of skin closure, administered over 10 minutes and caudal block using 1 ml/kg of bupivacaine 0. 25 % plus 2 ml normal saline.
干预措施: Propofol alone (Drug)
Group B (caudal dexmedetomidine group)
30 patients will receive caudal dexmedetomidine block using 1 ml/kg of bupivacaine 0. 25 % mixed with dexmedetomidie 1mic/kg diluted in 2 ml normal saline.
干预措施: Dexmedetomidine (Drug)
Group C (propofol with caudal dexmedetomidine group)
30 patients will receive both propofol .5 mg/kg before the start of skin closure, administered over 10 minutes and caudal dexmedetomidine block using 1 ml/kg of bupivacaine 0. 25 % mixed with dexmedetomidie 1mic/kg diluted in 2 ml normal saline.
干预措施: dexmedetomidine + propofol (Drug)
结局指标
主要结局
postoperative EA
时间窗: 24 hours
The incidence of postoperative emergence agitation in the study groups will be evaluated by using the (PAED Score)
次要结局
未报告次要终点
研究者
Abudaif Abdelrazzak Abudaif eid
Resident
Assiut University