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临床试验/CTRI/2023/01/049139
CTRI/2023/01/049139尚未招募不适用

Comparison of effect of intravenous Dexmedetomidine, Esmolol and combination of Esmolol and Dexmedetomidine for attenuation of hemodynamic stress response to laryngoscopy and endotracheal intubation.

ABVIMS AND DR RML HOSPITAL1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2023年2月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
63
试验地点
1
主要终点
Hemodynamic response to Laryngoscopy and Endotracheal Intubation(HR,SBP,DBP,MAP)

研究概览

简要总结

Patients posted for elective surgeries under general anaesthesia will be assessed according to eligibility criteria. A total of 63 (21 in each group) patients will be selected. The procedure will be explained to the patients and informed, written consent will be obtained in a language that is understood by the patient. All standard monitors will be attached and baseline heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) will be recorded. Intravenous access will be established and a venous sample for baseline serum cortisol and blood sugar levels will be taken. According to randomization into 3 groups, patients will be administered intravenous Dexmedetomidine (1 mcg/kg) in group 1, Esmolol (1 mg/ kg) in group 2 and combination of Esmolol (0.5 mg/kg) and Dexmedetomidine (0.5 mcg/kg) in group 3. Induction will be done followed by Laryngoscopy and Endotracheal Intubation. Hemodynamic monitoring will be done at 1, 3 and 5 minutes post-intubation and blood sampling for biochemical markers will be done at 5 minutes post-intubation. Statistical methods will be used to analyse collected data.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • American society of Anaesthesiologists(ASA) Physical status I and II Patients
  • Either sex
  • Age: 20 to 50 years
  • Elective surgical procedures.

排除标准

  • Known sensitivity to any study drug
  • Pregnant females
  • Patient with chronic hypertension and diabetes mellitus
  • Patient with history of cardiac or respiratory disease
  • Patient with anticipated difficult airway
  • Patient with impaired kidney or liver function
  • Patient on Beta blockers.

结局指标

主要结局

Hemodynamic response to Laryngoscopy and Endotracheal Intubation(HR,SBP,DBP,MAP)

时间窗: Baseline(at arrival in OT) | 1 minute after Laryngoscopy and Endotracheal Intubation | 3 minutes after Laryngoscopy and Endotracheal Intubation | 5 minutes after Laryngoscopy and Endotracheal Intubation

次要结局

  • Biochemical markers of stress response(Serum cortisol and Blood glucose levels)(Baseline(at arrival in OT))

研究者

发起方
ABVIMS AND DR RML HOSPITAL
申办方类型
Government medical college

研究点 (1)

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