Comparison Study Between Intrathecal and Intravenous Dexmedetomidine in Lower Limb Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- First request to analgesia
研究概览
简要总结
A prospective, randomized, comparative controlled clinical trial, aiming to compare the use of intrathecal dexmedetomidine by intravenous dexmedetomidine in concern of the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.
详细描述
Seventy patients undergoing lower limb surgeries were included in this study. Using a random number sequence, patients were enrolled in one of two groups: Group T receiving 5 µg of dexmedetomidine (Precedex® 100 µg/mL, Hospira, Inc., IL, U.S.A.) combined with 12.5 mg of 0.5% hyperbaric bupivacaine (Marcaine® Spinal Heavy; Astra, Sodertalje, Sweden) and Group V receiving the same bupivacaine DOSE AND 0.75 microgram/kilogram of body weight dexmedetomidine intravenously. Dexmedetomidine 100 µg/mL was mixed with preservative-free normal saline to 10 µg/mL. The 0.5 mL of dilute dexmedetomidine was added to the bupivacaine in group T. An independent investigator prepared the drug solutions and provided the coded drug to the anaesthetic administrator before the start of the anaesthesia. The anaesthetic administrator, patients, outcome assessors, and data analysts were blinded to the allocation. Spinal Anesthesia Patients were hydrated with 500 mL of 0.9% sodium chloride solution before anaesthesia. The spinal puncture was performed at L3-4 or L4-5 with a midline approach using a 25 G Quincke needle in the lateral decubitus position. After confirmation of free flow and clear cerebrospinal fluid, the drug was administered and the patients were then placed in the supine neutral position.
Assessment: The primary end-point of this study was the first request to analgesia. The secondary end-points were the total postoperative analgesic consumption as well as the VAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II patients
- •age 18-65 years
- •scheduled for lower limb surgery
- •spinal anaesthesia
排除标准
- •patients with coagulopathy
- •infection at the site of lumbar puncture
- •beta-blockers or calcium channel blockers usage
- •hypersensitivity to Bupivacaine or Dexmedetomidine
- •any other contra-indications for spinal anaesthesia.
研究组 & 干预措施
IT intrathecal
administration of intrathecal dexmedetomidine in addition to bupivacaine for lower limb surgeries
干预措施: Dexmedetomidine (Drug)
IV intravenous
administration of intravenous dexmedetomidine in addition to spinal anaesthesia for lower limb surgeries
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
First request to analgesia
时间窗: Postoperative up to 24 hours
The first time the patient is asking for analgesia to control his pain
次要结局
- Total postoperative analgesia consumption(Postoperative up to 24 hours)
- visual analogue scale(Every two hours for 24 hours postoperative)
研究者
Abdelrhman Alshawadfy
Lecturer of anesthesia and intensive care
Suez Canal University
