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临床试验/CTRI/2019/04/018416
CTRI/2019/04/018416招募中不适用

A comparative study between Dexmedetomidine nebulisation and intravenous Dexmedetomidine on attenuation of sympathoadrenal response to laryngoscopy and intubation under general anaesthesia

Dr Megha V1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2019年4月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Dexmedetomidine nebulisation effectively attenuates pressor response to laryngoscopy and intubation when compared to dexmedetomidine given intravenously , efficacy parameter being hemodynamic parameters ( heart rate, systolic BP, diastolic BP, mean arterial pressures, SpO2

研究概览

简要总结

Laryngoscopy and endotracheal intubation increase the plasma concentration of catecholamines due to sympathetic stimulation which can result in tachycardia and hypertension in most of the individuals. These changes peaks in 1–2 min and returns to normal levels inside 5-10 minutes after intubation. Dexmedetomidine, a selective α2 receptor agonist, decreases sympathetic tone and has been demonstrated to reduce the stress response to laryngoscopy and intubation when given as a premedication intravenously, but studies related to nebulised dexmedetomidine in attenuation of intubation response are not available. Hence this study is designed to compare the efficacy and safety of  dexmedetomidine through nebulisation route.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant 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 who have given written informed consent
  • Patients with ASA grade I & II.
  • Patients aged 18-60 years.
  • Patients with BMI 19-28 kg/m2
  • Patients scheduled for elective surgery under general anaesthesia.

排除标准

  • Patients not willing to give written informed consent.
  • Patients with history of allergy to dexmedetomidine..
  • Patients with anticipated difficult mask ventilation/difficult intubation.
  • Patients with baseline heart rate < 60 bpm and systolic blood pressure < 100 mm Hg
  • Patients with coronary heart disease, ischemic heart disease, heart blocks, diabetes mellitus.
  • Pregnant women/Breastfeeding mothers.

结局指标

主要结局

Dexmedetomidine nebulisation effectively attenuates pressor response to laryngoscopy and intubation when compared to dexmedetomidine given intravenously , efficacy parameter being hemodynamic parameters ( heart rate, systolic BP, diastolic BP, mean arterial pressures, SpO2

时间窗: Baseline | Before drug | After drug | Before induction | After induction | Immediate after intubation | 1 min after intubation | 2 min after intubation | 5 min after intubation | 10 min after intubation

次要结局

  • dexmedetomidine nebulisation may have lesser side effects like bradycardia, hypotension, dizziness ,post operative sedation etc.(Intra-operative)

研究者

发起方
Dr Megha V
申办方类型
Other [Self ]

研究点 (1)

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