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临床试验/CTRI/2018/05/014172
CTRI/2018/05/014172已完成Unknown

Comparison of Esmolol and Lignocaine in Attenuation of Stress Response to Laryngoscopy and Intubation

Sree Gokulam Medical College And Research Foundation1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年9月26日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Prevention of rise in Blood Pressure and Heart Rate due to laryngoscopy and intubation

研究概览

简要总结

Hypertension and tachycardia occurring during laryngoscopy and intubation could be deleterious to certain patients. The present study was designed to compare the effectiveness of Esmolol and Lignocaine in attenuating the stress response to laryngoscopy and intubation in 60 normal healthy patients of ASA grade I and II , of either sex , in the age group of 18-60 years for elective noncardiac surgery requiring general anaesthesia. This was done by noting the pressor response variables namely Heart rate, Systolic blood pressure, Diastolic blood pressure and Mean arterial pressure. The trends of these parameters were noted at frequent intervals in the first 8 minutes after induction of anaesthesia. There were no arrythmias. The results were statistically analysed . Compared with the Lignocaine group, the attenuation of stress response variables were better in the Esmolol group. Esmolol was found to be more effective than Lignocaine  in controlling the stress response to larngoscopy and intubation. Esmolol 1 mg/kg was found to be safe and effective  in controlling the pressor response to laryngoscopy and intubation.

研究设计

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

  • ASA I, II Mallampatti Class I or II Age : 18-60 yrs Weight : 40 – 90 kg Elective non-cardiac surgery.

排除标准

  • Heart rate <70/mt.
  • Basal systolic BP<100mm Hg H/o of asthma, cardiac disease & presence of heart block.
  • ASA PS > II Anticipated difficult intubation Anxious or apprehensive patients Intubation time more than 15 seconds.

结局指标

主要结局

Prevention of rise in Blood Pressure and Heart Rate due to laryngoscopy and intubation

时间窗: T0 : Baseline recording on entering the operating room. | T1 :Just before induction | T2 : During laryngoscopy and intubation | T3 :1 min after laryngoscopy | T4 : 3 min after laryngoscopy | T5: 5 min after laryngoscopy

次要结局

  • Assessment of safety of Esmolol and Lignocaine administered ( monitoring for arrythmias)(T0 : Baseline recording on entering the operating room.)

研究者

发起方
Sree Gokulam Medical College And Research Foundation
申办方类型
Private medical college

研究点 (1)

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