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临床试验/CTRI/2013/06/003741
CTRI/2013/06/003741已完成Unknown

COMPARISION OF EFFECTIVENESS OF DEXMEDETOMIDINE VS ESMOLOL IN BLUNTING OF CARDIOVASCULAR RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION IN TREATED HYPERTENSIVES

未提供1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2011年2月5日最近更新:

试验速览

阶段
Unknown
状态
已完成
入组人数
90
试验地点
1
主要终点
To compare the effectiveness of dexmedetomidine versus esmolol in blunting of the hemodynamic and bispectral index(BIS) response to laryngoscopy and intubation in treated hypertensive patients undergoing elective surgery

研究概览

简要总结

Hypertension    and     tachycardia     are   frequently   associated   with   direct   laryngoscopy    and   endotracheal   intubation(LETI)   after   induction  of   anaesthesia. Patients  with   hypertension,     both   treated    and     untreated, are  prone to exaggerated   pressor    response    to  LETI  than  are normotensive   patients.The exaggerated  pressor  response to LETI  in  these patients  can  evoke life-threatening   condtions  which include myocardial  ischemia,  pulmonary oedema, cardiac  failure  and cerebral  haemorrhage. Few   studies  have   been   carried out with consideration to attenuate   the   hemodynamic response  to  laryngoscopy  in  the subgroup   of    patients    with   hypertension. Nitroglycerine,  verapamil,diltiazem, esmolol, alfentanil and   remifentanil   have been used of whichesmolol was found to be most effective. Dexmedetomidine, a clonidine-like α2-agonistis a sedative-hypnotic and  analgesic. The mechanism by whichdexmedetomidine produces its actions is mainly through central sympatholysisand decreased circulating levels of catecholamines. Since cardiovascular responseto LETI is sympathetically driven, it can be catastrophic, especially inhypertensives due to their enhanced sensitivity to circulating catecholamines.It is therefore hypothesised that dexmedetomidine can effectively blunt thesympatho-adrenal response to LETI, thereby resulting in decreased morbidity inhypertensive patients. Hence this present study aims to study a new drugdexmedetomidine against the previously established drug esmolol in blunting ofcardiovascular response to LETI.

研究设计

研究类型
Interventional
分配方式
Random Number Table
盲法
Double Blind Double Dummy

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Ninety patients of ASA physical status II & III, of either sex, aged between 35-65 years and undergoing elective surgery requiring general anaesthesia will be included in the study.
  • Controlled hypertensive patients with blood pressure less than 160/100 mmHg receiving oral antihypertensive medication for a minimum period of six weeks will be studied.

排除标准

  • Patients with anticipated difficult intubation •Physical status > ASAIII •Hiatus hernia, gastro-oesophageal reflux disease •Obesity ( BMI > 30 kg/m2) •Those on long-term sedatives, hypnotics, antidepressants, drugs affecting nervous system •Previous myocardial infarction or angina pectoris, congestive heart failure • Heart blocks •Neurosurgical patients •History of allergy to dexmedetomidine or esmolol.

结局指标

主要结局

To compare the effectiveness of dexmedetomidine versus esmolol in blunting of the hemodynamic and bispectral index(BIS) response to laryngoscopy and intubation in treated hypertensive patients undergoing elective surgery

时间窗: It will be a randomized double- blind study conducted between january 1st 2011 to December 31st 2011(one year).

次要结局

  • The study also aims at measuring dexmedetomidine’s effect on isoflurane requirements.(It will be a randomized double- blind study conducted between january 1st 2011 to December 31st 2011(one year).)

研究者

发起方
未提供

研究点 (1)

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