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临床试验/CTRI/2017/03/008044
CTRI/2017/03/008044招募中4 期

Comparison between dexmedetomidine and midazolam for emergence agitation after nasal surgeries

Shri Sathya Sai Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2016年5月9日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
To compare incidence of emergence agitation between Inj Dexmedetomidine and Inj Midazolam group.

研究概览

简要总结

This is randomised comparison between two drugs, Inj Midazolam and Inj Dexmedetomidine for prevention of emergence agitation following nasal surgeries.  After obtaining valid informed consent patients will receive drug as per allotment group. For Group I, 100 mcg of Inj dexmedetomidine would be added into normal saline to make total volume of 50 mL. For Group II, 5 mg of inj midazolam would be added to normal saline to make total of 50 mL. Infusions will be started as per mentioned earlier. All standard monitors would be connected and vitasl will be monitored as mentioned in outcomes. General anaesthesia will be induced with inj propofol 2mg/kg, Fentanyl 2mcg/kg and vecuronium 0.1 mg/kg.  Patients will be intubated with appropriate size entotracheal tube and will be maintained with oxygen , nitrous oxide, sevoflurane and inj vecuronium for relaxation. Additional analgesia will be decided by anaesthesiologist assigned to the case. Infusion and inhalational agents will be stopped at end of surgery when nasal packing is started. total duration of inhalational agent and time of discontinuation would be noted. Time from discontinuation to eye opening would be noted. patients would be reversed and extubated. Agitation score would be seen as per ’Riker’s agiatation sedation score’( RASS). Score of 5 and above will be taken as agitation and score of 3 and below will be taken as sedation.Patients would be monitored with same scale every 5 minutes for half an hour and then every 15 minutes for 2 hours.

研究设计

研究类型
Interventional
分配方式
Stratified block randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Posted for nasal surgeries 2.ASA physical status I and II
  • Elective surgeries.

排除标准

  • ASA physical status III and above
  • Heart disease and rhythm disturbances
  • psychiatric illness and anxiety disorder
  • History of post traumatic stress disorder
  • Emergency surgeries
  • Pregnancy
  • History of obstructive sleep apnea.

结局指标

主要结局

To compare incidence of emergence agitation between Inj Dexmedetomidine and Inj Midazolam group.

时间窗: At regaining consciousness, at extubation, every 5 minutes till 30 minutes are over

次要结局

  • To compare perioperative vitals, sedation and recovery profile(At baseline, at 5 minutes, at 15 minutes after starting drug infusion then every 15 minutes till end of surgery. sedation and recovery profile at return of consciousness, at extubation and then every 5 minutes for 30 minutes.)

研究者

发起方
Shri Sathya Sai Medical College and Research Institute
申办方类型
Private medical college

研究点 (1)

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