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临床试验/NCT04646317
NCT04646317Unknown早期 1 期

To Observe the Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy.

Dr. Ruth K.M. Pfau Civil Hospital, Karachi1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年12月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
44
试验地点
1
主要终点
Change in Systolic blood pressure during pneumoperitoneum

研究概览

简要总结

Dexmedetomidine provides better hemodynamic stability to the patients with hypertension undergoing laparoscopic cholecystectomy.

详细描述

Laparoscopic surgeries form an essence of today's surgical practice because of its magnification, less cosmetic scar, less postoperative pain, and decreased hospital stay along with less morbidity and mortality.

According to the American Heart Association (AHA), approximately 86 million adults (34%) in the United States are affected by hypertension, which is defined as a systolic blood pressure (SBP) of 140 mm Hg or more or a diastolic blood pressure (DBP) of 90 mm Hg or more, taking anti-hypertensive medication of those with high blood pressure (BP), 78% were aware they were hypertensive, 68% were being treated with anti-hypertensive agents, and only 64% of treated individuals had controlled hypertension.

Anaesthetic management in these patients has become complicated due to cardiopulmonary changes occurring during creation of pneumoperitoneum with CO2 and patient position required for different laparoscopy surgeries. Effects of pneumoperitoneum for laparoscopic surgeries on heart rate and blood pressure was recognized more than 50years ago and the magnitude of the changes was observed to depend on the depth of anesthesia. The cardiovascular, neuroendocrine, and renal changes induced by the CO2 pneumoperitoneum produce a complex pathophysiological state remarkably similar to that in patients with chronic heart failure, though the initiating event is clearly very different. In normotensive subjects these hemodynamic changes are short lived5and probably of little significance. However, these haemodynamic alterations are hazardous to the patients with hypertension, myocardial insufficiency or cerebrovascular disease.

Various pharmacologic and nonpharmacological methods have been tried to limit the pressor response following the creation of pneumoperitoneum. The success rate is variable with different methods because each method has its own merits and demerits. In several clinical trials drugs like opioids, β-blockers, lidocaine, nitrate calcium channel blockers or magnesium have already been used orally or parenterally to obtund this sympathoadrenal response. Recently, there is considerable interest in the use of α2-adrenergic agonists to provide hemodynamic stability during pneumoperitoneum.

Dexmedetomidine famous for its awake sedation is eight times more selective than clonidine for the α2-adrenergic receptors. The ratio of α2:α1 activity of dexmedetomidine is 1620:1. It activates pro-survival kinases and attenuates ischemia and hypoxic injury, including cardio protection. Concurrent infusion during surgery reduces anesthetic consumption by 20-50% , and produces a decrease in heart rate and blood pressure that may be advantageous for hypertensives. Hypertension associated to pneumoperitoneum in normotensive patients has been controlled with the loading dose of dexmedetomidine. So our rational is to see the hemodynamic stability of dexmedatomindine in hypertensive patients undergoing pneumoperitoneum.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

盲法说明

Patients and care provider do not know about the interventions

入排标准

年龄范围
17 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hypertensive patients of both genders of age 17 years to 70 years who are undergoing laparoscopic cholecystectomy.
  • ASA II and III

排除标准

  • Patients with a prior history of cardiac disease like ischemic heart disease, valvular disorders, undergone previous valve replacements, infective endocarditis and rheumatic fever.
  • Renal diseases like acute kidney injury and chronic renal diseases.
  • Endocrinal diseases like pheochromocytoma, hyperthyroidism, hypothyroidism, cushing disease etc.
  • Pregnant and lactating females
  • Short thick neck with anticipated difficult intubation
  • Any sort of obstructive restrictive or reactive airway disease
  • Patient allergic to any of the study medications.
  • Obese patients (BMI>35)
  • Narcotic addicts

研究组 & 干预措施

Dexmedetomidine

Experimental

Dexmedetomidine infusion four 50 ml syringes containing 1 microgram per ml dexmedetomidine

干预措施: Dexmedetomidine injection (Drug)

normaL SALINE 0.9%

Placebo Comparator

Four 50 ml syringes of .9 % Normal SALINE

干预措施: Normal Saline (Drug)

结局指标

主要结局

Change in Systolic blood pressure during pneumoperitoneum

时间窗: From baseline to the end of pneumoperitonium, an average of 2 hours

Systolic blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively

change in Mean Arterial blood pressure during pneumoperitoneum

时间窗: from baseline to the end of pneumoperitoneum, an average of 2 hours

Mean Arterial blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively

change in Heart Rate during pneumoperitoneum

时间窗: from baseline to the end of pneumoperitoneum, an average of 2 hours

Heart rate will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively

change in Diastolic blood pressure during pneumoperitoneum

时间窗: from baseline to the end of pneumoperitoneum, an average of 2 hours

Diastolic blood pressure will be noted on baseline, after induction, every 5 minutes after induction to the end of pneumoperitonium and every 5 minutes for 30 minutes post operatively

次要结局

  • Diastolic Blood pressure intubation(Induction)
  • Systolic blood pressure intubation(Induction)
  • Mean Arterial blood pressure intubation(Induction)
  • heart rate intubation(Induction)
  • Post operative sedation(every 5 minutes, up to 30minutes)
  • Complication(every 5 minutes from induction, up to 30 minutes post procedure)
  • Post operative analgesia(every 5 minutes, up to 30minutes)

研究者

发起方
Dr. Ruth K.M. Pfau Civil Hospital, Karachi
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Muhammad Imran Riasat

Senior Registerar

Dr. Ruth K.M. Pfau Civil Hospital, Karachi

研究点 (1)

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