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临床试验/NCT03460041
NCT03460041Unknown4 期

Caudal Dexmetedomedine Versus Magnesium in Orthopedic Pediatric Surgeries

Hagar hassanein refaee1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2017年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
36
试验地点
1
主要终点
Postoperative pain

研究概览

简要总结

This study will be performed in Abo Elreesh Pediatric Hospital / Cairo University after obtaining approval by the University Ethics Committee, and a written informed consent from the parents or guardians.

Thirty six patients will be randomly assigned using an online randomization program (http://www.randomizer.org) and the sealed envelope method into three groups: Group D (n=12): Dexmetedomidine group. 0.5 ml of dexmetedomidine (2 μg/kg) added to bupivacaine, Group M (n=12) : Magnesium group.0.5 ml of magnesium sulphate (50 mg) added to bupivacaine, Group C (n=12) :Control group.bupivacaine 0.25% diluted in normal saline with total volume of 1 ml/kg.

详细描述

History regarding previous anesthesia, surgery, any significant medical illness, medications and allergy will be taken for all children who will be enrolled in the study. Complete physical examination and airway assessment will be done. Hemoglobin percentage, blood sugar and coagulation profile will be investigated preoperatively Sedation will be done by giving midazolam (0.2 mg/kg IM).On arrival to the operating room all patients will be monitored by 5 leads electrocardiography (ECG), automated non-invasive blood pressure monitoring (NIBP), and pulse oximetery.

Inhalational induction of anesthesia will be achieved by 8% sevoflurane in 100% oxygen and an appropriate-sized cannula will be inserted. Endotracheal intubation will be performed after which sevoflurane concentration will be reduced to 3%. After hemodynamic stabilization, caudal block will be performed by using beveled needle 18-23 G in the lateral decubitus position by using the loss of resistance technique. The study solutions will be injected caudally slowly with repetitive intermittent aspiration by an anesthesiologist blinded to the test drugs. The inhaled concentration of sevoflurane will be adjusted to achieve hemodynamic changes less than 30% of the preoperative values

Recorded Parameters for the study:

Intraoperative hemodynamic: heart rates (beats/minutes), mean arterial blood pressure (mmHg) after stabilization, before skin incision and every 15 minutes till the end of surgery.

Sedation score: Sedation will be monitored after PACU arrival using Ramsay score with its 0-6 score range.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 1 - 7 years old.
  • American Society of Anesthesiologist (ASA) physical status class I- II.
  • Patients scheduled for infra-umbilical orthopedic surgeries.

排除标准

  • Patients with known allergy to the study drugs
  • Suspected coagulopathy.
  • Infection at the site of caudal block.
  • History of developmental delay or neuromuscular disorders.
  • Skeletal deformities.
  • Patients on magnesium therapy

研究组 & 干预措施

Control

Placebo Comparator

干预措施: Bupivacaine (Drug)

Magnesium

Active Comparator

干预措施: Magnesium Sulfate (Drug)

Dexmetedomedine

Active Comparator

干预措施: Dexmetedomedine (Drug)

结局指标

主要结局

Postoperative pain

时间窗: 12 hours

Comparing duration of analgesia between caudal magnesium and caudal dexmetedomedine using flacc score

次要结局

未报告次要终点

研究者

发起方
Hagar hassanein refaee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hagar hassanein refaee

Assistant lecturer

Cairo University

研究点 (1)

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