Association of Different Doses of Clonidine in Caudal Epidural Anesthesia for Hypospadias Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption
研究概览
简要总结
The use of increasing doses of clonidine ssociated to bupivacaine in caudal epidural block provides better postoperative analgesia compared whit analgesia provide by bupivacaine alone
It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity , cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable.
详细描述
It is a randomized, double blind study, involving 80 children with ages from 1 to 10 years old, following eletive hypospadias surgery, under general anesthesia and caudal epidural block . The patients will be divided into 4 groups: bupivacaine alone, bupivacaine plus clonidine 1mcg/kg, bupivacaine plus clonidine 2 mcg/kg, bupivacaine plus clonidine 3 mg/kg. The peroperative consumption of anesthetics gases, heart rate and arterial blood pressure will be recorded. Postoperative pain will be evaluated by using FLACC scale ( faces , legs, activity, cry , consolability ) . Requiriments for supplementary postoperative analgesia at 24 h will be avaiable. Postoperative hemodynamics parameters will be recordes at 24 h.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 10 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •CHildren 1 - 10 years old.
- •ASA I E II ( American Society of Anesthesiology)
- •hypospadias surgery
排除标准
- •parents refuse
- •Infection
- •Coagulation disorders
- •Allergy to anesthetics
- •Abnormalities of the sacral spine
研究组 & 干预措施
Clonidine 1 mcg/Kg
IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 1 mcg/ Kg of clonidine for hypospadia surgery
干预措施: Clonidine 1 mcg/Kg (Drug)
Clonidine 2 mcg/ Kg
IGeneral Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 2 mcg/ Kg of clonidine for hypospadia surgery
干预措施: Clonidine 2 mcg/ Kg (Drug)
Clonidine 3 mcg/Kg
General Anesthesia associated with caudal anesthesia with Bupivacaine 0,166% plus 3 mcg/ Kg of clonidine for hypospadia surgery
干预措施: Clonidine 3 mcg/ Kg (Drug)
结局指标
主要结局
Analgesia and efficacy of a bupivacaine-clonidine mixture measured through postoperative morphine consumption
时间窗: 24 hours after the surgery
次要结局
未报告次要终点
研究者
Renato Santiago Gomez
PhD
Federal University of Minas Gerais