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临床试验/CTRI/2024/05/067921
CTRI/2024/05/067921招募中4 期

Efficacy of intranasal versus intravenous nitroglycerine in laparoscopic cholecystectomy - A Randomized controlled trial.

Dr Shruti Panda1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2024年6月20日最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
111
试验地点
1
主要终点
To evaluate the effect on Mean Arterial Pressure.

研究概览

简要总结

Nitroglycerine is an organic nitrate which is a venous as well as arterial dilator which releases nitric oxide and causes relaxation of vascular smooth muscles. Dilation of larger veins promotes peripheral pooling of blood which in turn reduces preload. At higher doses, it leads to arterial relaxation which reduces systemic vascular resistance and hence, the afterload.

There are few studies available in the literature regarding the use of intranasal nitroglycerine and intravenous nitroglycerine for attenuation of pressure response. Intranasal nitroglycerine as an alternative to conventional intravenous route has recently been shown to have positive perioperative outcomes in multiple studies. The preferable route of nitroglycerine administration to achieve this without causing much side effects is not yet clear. Hence, this study is designed to find out preferable route of nitroglycerine administration for reducing the hypertensive response to pneumoperitoneum.

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

  • 1.Age 18 to 60 yrs of either sex.
  • 2.ASA Physical class I and II posted for elective laparoscopic cholecystectomy.

排除标准

  • 1.Systolic blood pressure less than 90 mm Hg. 2.Allergy to nitrates.
  • 3.Patients who are on Phosphodiesterase Inhibitors, Antihypertensives or sympathomimetics 4.Patients with known nasal pathologies.

结局指标

主要结局

To evaluate the effect on Mean Arterial Pressure.

时间窗: T0 – 3 mins before pneumoperitoneum | T1- At the time of pneumoperitoneum | T2 – 2 mins after pneumoperitoneum | T3 – Every 2 mins for first 10 mins | T4- Every 15 mins till end of surgery

次要结局

  • 1)Effect on SBP,DBP,HR at various time intervals(2)To study the incidence of PONV, headache.)

研究者

发起方
Dr Shruti Panda
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr. Shruti Panda

Kalinga Institute of Medical Sciences, Bhubaneswar

研究点 (1)

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