Subtenon Versus Intravenous Dexmedetomidine for Postoperative Analgesia and Vomiting Control in Infantile Cataract Surgery
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- postoperative CRIES pain scale score
研究概览
简要总结
The purpose of the present study was to evaluate the efficacy and safety of subtenon block (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract surgery.
详细描述
In this prospective, randomized, controlled, double blind trial eighty ASA physical status grade I and II infants (1-12month) undergoing elective cataract surgery in one eye under general anesthesia were studied. Infants were randomly allocated to one of the two groups: subtenon block Group (SB) with dexmedetomidine (n =40) or intravenous dexmedetomidine Group (IV) (n =40). After securing the airway, infants in Group (SB) received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture, whereas infants in Group (IV) received 1µ/kg IV dexmedetomidine after induction of anesthesia. Surgery started after 5 min of study drug administration. Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics was the primary outcome. CRIES pain scale score , vomiting scale score during4-h study period, incidence of oculocardiac reflex and any surgical difficulty were the Secondary outcomes.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status grade I and II infants (1-12month).
- •undergoing elective cataract surgery in one eye under general anesthesia.
排除标准
- •infection of the orbit,
- •increased intraocular pressure(IOP),
- •history of allergy to local anesthetics,
- •history of previous eye surgery,
- •cardiovascular or clotting disorders,
- •full stomach,inner ear disorders or other conditions predisposing to vomiting
- •airway abnormalities
- •compromised sclera.
研究组 & 干预措施
subtenon block Group (SB)
received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture
干预措施: SB dexmedetomidine bupivacaine block (Drug)
intravenous dexmedetomidine Group(IV)
received 1µ/kg IV dexmedetomidine after induction of anesthesia
干预措施: intravenous dexmedetomidine (Drug)
结局指标
主要结局
postoperative CRIES pain scale score
时间窗: 4 hours postoperatively
(0-2 for each parameter)
Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics
时间窗: 4 hours postoperatively
by analysis for number of infants withCRIES pain scale score \>3
次要结局
- Number of oculocardiac reflex(OCR)events(acute reduction in heart rate of >20%).(intraoperative period)
- vomiting scale score(4 hours postoperative)
研究者
jehan ahmed sayed
assistant professor in anesthesia and intensive care department,faculty of medicine assiut university
Assiut University