跳至主要内容
临床试验/CTRI/2017/03/008077
CTRI/2017/03/008077尚未招募Phase 3 4

A comparative study to evaluate the efficacy of dexmedetomidine as a hypotensive agent in comparison to esmolol in ASA grade 1-2 patients undergoing ENT surgeries.

Dr Shilpa bansal1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年1月4日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
primary outcome is to compare the quality of the surgical field using a predefined category scale

研究概览

简要总结

This study is a prospective, randomised ,double blind, parallel group with active controlled trial to comparethe efficacy and safety of dexmedetomidine with Esmolol as a hypotensive agent in  60  (30 in each group) ASA grade I-II patients of both sexes aged between 18-60 yrs, undergoing Otorhinolaryngeal (ENT) surgeries with attention on theamount of blood loss, quality of the surgical field as primary outcome measures and analgesia requirement, recovery profile, andtolerability in adult patients as secondary outcome measures.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and 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

  • Patients aged 18- 60 yrs of both the sexes, undergoing planned Otorhinolaryngeal (ENT) surgeries with ASA grade I-II.

排除标准

  • 1.Patients refusing to give informed consent.
  • 2.Patients with recurrent sinus surgery and patients with systemic co-morbidities like hypertension, coronory artery disease, renal or hepatic disease, cerebro vascular accidents.
  • 3.Patients with coagulopathies or receiving drugs which have effects on coagulation profile.

结局指标

主要结局

primary outcome is to compare the quality of the surgical field using a predefined category scale

时间窗: surgical field score

次要结局

  • compare the efficacy and safety of dexmedetomidine with Esmolol as a hypotensive agent in ENT surgeries with attention on analgesia requirement, recovery profile, and tolerability in adult patients.(sedation score, visual analogue score, modified aldrete score)

研究者

发起方
Dr Shilpa bansal
申办方类型
Private medical college

研究点 (1)

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