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临床试验/CTRI/2025/07/090927
CTRI/2025/07/090927尚未招募Unknown

Attenuation of hemodynamic stress responses during extubation with intravenous diltiazem versus intravenous lignocaine in patient undergoing elective laparoscopic surgeries - a prospective randomised control study

SALMANISHA S A1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2025年7月25日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
78
试验地点
1
主要终点
To assess and compare the attenuation of hemodynamic stress responses with intravenous diltiazem versus intravenous lignocaine during extubation in patient undergoing elective laparascopic surgeries

研究概览

简要总结

Endotracheal extubation is the translaryngeal removal of a tube from the trachea via the nose or mouth. Endotracheal extubation almost always associated with haemodynamic changes due to reflex sympathetic discharge caused by epipharyngeal and laryngopharyngeal stimulation. This increase in sympathoadrenal activity may result in hypertension tachycardia and arrhythmias. In addition, many other stimuli affect these hemodynamic changes including pain from wound and emergence from anaesthesia.These hemodynamic changes during extubation and emergence from anesthesia may cause dangerous increases in myocardial oxygen demand in patients with coronary artery disease CAD and in those with risk factors for CAD.

Laparoscopic procedures are also associated with several undesirable cardiorespiratory perturbances. A combination of several factors, namely pneumoperitoneum, patient position, anaesthesia and hypercapnia from the absorbed CO2 are responsible for the haemodynamic changes observed during laparoscopy. These includes increased HR increased arterial pressures, increased systemic vascular resistance and increased pulmonary vascular resistance. Hemodynamic changes induced by the pneumoperitoneum and more particularly the increased systemic vascular resistance outlast the release of the pneumoperitoneum. Thus, at the end of the procedure, even when intra-peritoneal pressure has returned to normal the heart rate and arterial pressure remain elevated. These changes may add on to the changes provoked by extubation.Many pharmacological methods have been devised to reduce the extent of hemodynamic events, including esmolol, alfentanil, fentanyl, diltiazem, high dose of opioids, local anaesthetics like lignocaine and vasodilating drugs like nitroglycerine.

Lignocaine, a sodium channel blocker, attenuates the hemodynamic response to tracheal extubation by inhibiting sodium channels in the neuronal cell membrane, decreasing the sensitivity of the heart muscles to electric impulses. Diltiazem, a calcium channel blocker, attenuates hemodynamic response by blocking voltage sensitive L type channels and inhibiting calcium entry mediated action potential in smooth and cardiac muscle. So, the present study was undertaken to study and compare the effect of intravenous diltiazem and intravenous lignocaine on attenuation of hemodynamic responses to endotracheal extubation in patients undergoing laparoscopic surgeries.

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 65.00 Year(s)(—)
性别
All

入选标准

  • weight 40 to 80kg height 150 to 170cm american society of anaesthesiologists physical status 1 and 2 patients with informed valid written consent.

排除标准

  • 未提供

结局指标

主要结局

To assess and compare the attenuation of hemodynamic stress responses with intravenous diltiazem versus intravenous lignocaine during extubation in patient undergoing elective laparascopic surgeries

时间窗: To look for attenuation of extubation resposes from the time of test drug administration to till 5 minutes after extubation

次要结局

  • adverse events , if any

研究者

发起方
SALMANISHA S A
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

SALMANISHA S A

KARNATAKA MEDICAL COLLEGE AND RESEARCH INSTITUTE

研究点 (1)

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