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临床试验/CTRI/2021/07/035201
CTRI/2021/07/035201尚未招募2 期

Comparative Evaluation of Two Different Doses of Intravenous Dexmedetomidine Infusion for Sedating Patients Undergoing Lower Abdominal General Surgical Procedures under Spinal Anaesthesia

Sapthagiri institute of medical sciences and research center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2021年7月31日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
To evaluate the effect of intravenous Dexmedetomidine infusion on sedation and duration of analgesia.

研究概览

简要总结

Subarachnoidblock is a widely used regional anaesthetic technique particularlyadvantageous for lower abdominal surgeries (l).Many spinal and epidural anaesthetic failed because of inadequate intravenous sedation and anxiolysis ratherthan technically flawed blocks .As unsedated patient may be apprehensive anduncooperative to the surgical procedure inspite of having adequate levels ofanalgesia by spinal anesthesia . Patients are often reluctant to remain awake during a procedure and the  requirement to maintain uncomfortablepositioning throughout the  surgery oflong duration can cause spontaneous movements which may interfere with thesurgical procedure. Therefore, provision of adequate sedation is important if the advantages of spinal anaesthesiato be fully appreciated.Theliterature review has few studies to asessthe efficacy of  intravenous ( IV )dexmedetomidine infusion on  spinalanesthesia block characteristics however , there are no studies till date to asessits efficacy on sedation or to evaluate the ideal dose of  IV dexmedetomineinfusion for sedation .Hencethis study has been formulated to compare two different doses of dexmedetomidine infusion to provide  continuous sedation in patients undergoinglower abdominal general surgical procedures under spinal anesthesia

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor 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

  • American society of anaesthesiology (ASA) physical status 1 and 2 patients.

排除标准

  • Patients undergoing laparoscopic surgeries.
  • Patients who have arrhythmia , heart failure , liver failure , renal failure or bleeding tendencies.
  • Patients with heart blocks , on calcium channel blockers and betablockers.
  • Allergic to study drug and local anesthetic.
  • Those who are not willing to participate in the study.

结局指标

主要结局

To evaluate the effect of intravenous Dexmedetomidine infusion on sedation and duration of analgesia.

时间窗: For intraoperative period and for 24 hours postoperatively.

次要结局

  • To evaluate hemodynamic changes and side effects of study drug if any.(For intraoperative period and for 24 hours postoperatively)

研究者

发起方
Sapthagiri institute of medical sciences and research center
申办方类型
Research institution and hospital

研究点 (1)

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