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临床试验/NCT04374318
NCT04374318已完成不适用

Comparison Study Between Intrathecal and Intravenous Dexmedetomidine in Lower Limb Surgeries

Suez Canal University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

administration of intrathecal dexmedetomidine in addition to bupivacaine for lower limb surgeries

干预措施: Dexmedetomidine (Drug)

IV intravenous

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abdelrhman Alshawadfy

Lecturer of anesthesia and intensive care

Suez Canal University

研究点 (1)

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