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临床试验/CTRI/2025/07/092130
CTRI/2025/07/092130尚未招募2/3 期

Comparison of intravenous lignocaine, esmolol and labetalol for attenuation of hemodynamic and stress response to laryngoscopy and endotracheal intubation under general anaesthesia.

未提供1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2025年8月11日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
入组人数
105
试验地点
1
主要终点
Haemodynamic parameters to laryngoscopy and endotracheal intubation (heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure)

研究概览

简要总结

PREANAESTHETIC EVALUATION:

A detailed pre-anesthetic checkup [PAC] including history, physical examination and

investigations as guided in accordance with the plan of surgery will be carried out in all patients.

The procedures will be explained to the patient and informed written consent will be obtained in a

language that is understood by the patient. The study drug will be administered according to the

group allocated to the patient. The observer will then collect the data.

ANAESTHETIC PROCEDURE:

On arrival in the operating room, standard monitors like pulse oximetry [SpO2],

electrocardiography[ECG] and non-invasive blood pressure[NIBP] are attached and

baseline hemodynamic parameters such as heart rate[HR] , systolic blood pressure [SBP],

diastolic blood pressure[DBP], mean arterial pressure[MAP] will be recorded in supine

position.

Intravenous line will be established by using 18 gauge or 20 gauge cannula and a venous

sample for Serum Cortisol levels and Blood Glucose will be taken at the same time.

Intravenous fluids will be started.

Based on the allocation of groups, patients will be pretreated with Lignocaine 1.5mg/kg,

Esmolol 1mg/kg, Labetalol 0.3mg/kg, 5 min prior to Laryngoscopy and oral Endotracheal

Intubation. Patients will be preoxygenated with 100% oxygen for 3 minutes. Anesthesia

will be induced with Propofol[2 mg/kg]. Following check ventilation, muscle relaxation

will be achieved with Vecuronium [0.1mg/kg] intravenously to facilitate Laryngoscopy

and Endotracheal intubation.

After 5 min of administration of study drugs, laryngoscopy and oral endotracheal

intubation will be performed using cuffed endotracheal tube of appropriate sizes and

hemodynamic parameters (HR, SBP, DBP, MAP) are recorded. Also on arrival in the

operating room, at 1 min, 3 min and 5 min following laryngoscopy and endotracheal

intubation hemodynamic parameters (HR, SBP, DBP, MAP) will be recorded. A venous

sample will be taken for serum cortisol and blood glucose levels on arrival in the operating

room and 5 minutes following Laryngoscopy and Endotracheal Intubation at the same time.

Anesthesia will be maintained with an inhalational agent and Oxygen: Nitrous Oxide

[50:50] throughout the surgery and ventilation adjusted to maintain EtCO2 of 30-40 mm

of Hg throughout the procedure.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

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 Grade I and II
  • Elective surgical procedure.

排除标准

  • Known sensitivity to any 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.

结局指标

主要结局

Haemodynamic parameters to laryngoscopy and endotracheal intubation (heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure)

时间窗: On arrival to OT, on laryngoscopy and intubation at 1 minute, 3 minutes and 5 minutes.

次要结局

  • Biochemical markers of stress response (serum cortisol and blood glucose levels).(At arrival in OT, 5 minutes after endotracheal intubation.)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Sushant

ABVIMS and Dr. Ram manohar lohia hospital, New Delhi

研究点 (1)

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