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临床试验/CTRI/2025/03/083669
CTRI/2025/03/083669尚未招募不适用

A Comparative Study Of Dexmedetomidine And Labetalol For Attenuation of Haemodynamic Stress Response to Laryngoscopy and Intubation: A Randomized Clinical Trial

Pranesh Gurung1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年4月10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
102
试验地点
1
主要终点
Haemodynamic changes ( hypertension, tachycardia, hypotension, bradycardia) during laryngoscopy and intubation.

研究概览

简要总结

Laryngoscopy during endotracheal intubation produce mechanical and chemical stimulus that increase somatovisecral reflex caused by stimulation of epipharynxand laryngopharynx producing tachycardia and hypertension which may produce deleterious effects on comorbid patients. Hence, it is important to find ways to attenuate those responses during laryngoscopy and intubation.

A comparative randomized clinical trial will be carried out to evaluate the efficacy of dexmedetomidine and labetalol in attenuating hemodynamic responses during laryngoscopy and intubation. This study will involve 102 American Society of Anaesthesiologist grade I and II patients aged 18to 60, of both sexes undergoing elective surgeries under general anaesthesia.

Patients will be randomly assigned to receive either dexmedetomidine (Group A) 1 mcg/kg in 10ml normal saline (n=51) or labetalol (Group B) 0.5 mg/kg in 10ml normal saline(n=51) intravenously 5 minutes before induction of anaesthesia. Haemodynamic parameters will be monitored 1 min after infusion of study drug followed by 1 min after induction and 1, 3, 5, 10 and 15 minutes after intubation.

The findings and observations made during the study will be tabulated, graphically represented.The inference drawn from this comparative study will provide insights into the effectiveness of dexmedetomidine compared to labetalol in attenuating haemodynamic responses during laryngoscopy and intubation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator 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

  • Patient of either sex Patient with ASA physical grade 1 and 2.

排除标准

  • Patient refusal Difficult airway Uncontrolled Hypertension Uncontrolled Diabetes Mellitus Ischemic heart disease Severe Renal disease Cerebrovascular disease Patient on beta blockers, alpha blockers Bronchial Asthma Allergy to study drugs.

结局指标

主要结局

Haemodynamic changes ( hypertension, tachycardia, hypotension, bradycardia) during laryngoscopy and intubation.

时间窗: Haemodynamic changes ( hypertension, tachycardia, hypotension, bradycardia) before starting infusion, 1 min after infusion, 1 min after induction, 1, 3 5, 15, 30 mins after intubation.

次要结局

  • Haemodynamic changes ( hypotension, bradycardia) during laryngoscopy and intubation.(Haemodynamic changes ( hypotension, bradycardia) before starting infusion, 1 min after infusion, 1 min after induction, 1, 3 5, 15, 30 mins after intubation.)

研究者

发起方
Pranesh Gurung
申办方类型
Other [Post Graduate Trainee]
责任方
Principal Investigator
主要研究者

Pranesh Gurung

Regional Institute Of Medical Sciences Imphal Manipur

研究点 (1)

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