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临床试验/NCT01964586
NCT01964586已完成4 期

Phase 4 Study of Comparison of Preincisional Infiltrated Dexmedetomidine and Lidocaine Plus Adrenaline for Surgical Conditions and Postoperative Analgesic Consumption in Nasal Sephoplasty Surgery.

TC Erciyes University0 个研究点目标入组 60 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
主要终点
surgical conditions

研究概览

简要总结

It is very important to decrease the bleeding during nasal septoplasty in order to increase the visibility of the surgical site. Our primary goal was to investigate the effects of dexmedetomidine and lidocaine plus adrenaline on visibility of surgical site and postoperative analgesic consumption.

详细描述

Nasal septoplasty is a surgery procedure which needs to have decrease the bleeding during the surgery for the visibility of surgical site.And postoperative pain is very usual after the surgery, so an effective postoperative analgesia procedure reduces the complications and helps to be discharged earlier from the hospital. An alpha 2 agonist Dexmedetomidine has an analgesic effect and vasoconstructive effect on the periferal blood vessels. Our hypothesis was dexmedetomidine makes a better surgecal conditions during the surgery and reduce the postoperative analgesic consumption. We administered the infiltrated dexmedetomidine or lidocaine plus adrenaline to the both side of the nasal septum 10 minutes before the surgery. Bleeding scores (Fromm and Boezaart Bleeding Scores) were recorded during the surgery. And postoperative analgesic consumptions were recorded in first 24 hours after the surgery.

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
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Scheduled for the nasal septoplasty surgery
  • ASA 1-2 patients
  • 18-60 yo patients

排除标准

  • Pregnant patients
  • ASA 3-4 patients
  • Under 18 yo childrens

研究组 & 干预措施

Lidocaine plus Adrenaline

Active Comparator

Lidocaine and adrenaline diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes from the surgery.

干预措施: Lidocaine (Drug)

Lidocaine plus Adrenaline

Active Comparator

Lidocaine and adrenaline diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes from the surgery.

干预措施: Adrenaline (Drug)

Dexmedetomidine

Active Comparator

2 mcg/kg dexmedetomidine diluted to 10 ml with normal salin and infiltrated to both side of the nasal septum before 10 minutes the surgery.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

surgical conditions

时间窗: during the surgery

Bleeding scores were recorded during the surgery

次要结局

  • Analgesic Consumption(Up to 24 hours)

研究者

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

Adnan Bayram

Asst Prof

TC Erciyes University

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