Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy

Study Overview
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Brief Summary
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Dexmedetomidine provides better hemodynamic stability to the patients with hypertension undergoing laparoscopic cholecystectomy.

Detailed Description
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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.

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

Conditions
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Hypertension, Laparoscopic Cholecystectomy

Intervention / Treatment
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* Drug: Dexmedetomidine injection
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypertensive patients of both genders of age 17 years to 70 years who are undergoing laparoscopic cholecystectomy. ASA II and III Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised control trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Dexmedetomidine infusion four 50 ml syringes containing 1 microgram per ml dexmedetomidine | Drug: Dexmedetomidine injection<br>* Infusion of dexmedetomidine will be prepared in Four syringes of 50ml containing dexmedetomidine in concentration of 1 microgram per millilitre.<br>* Other names: dexmedetomidine;|
| Placebo Comparator: normaL SALINE 0.9%<br>Four 50 ml syringes of .9 % Normal SALINE | Drug: Normal Saline<br>* 0.9% as placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic blood pressure during pneumoperitoneum | 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 | From baseline to the end of pneumoperitonium, an average of 2 hours | 
| change in Diastolic blood pressure during pneumoperitoneum | 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 | from baseline to the end of pneumoperitoneum, an average of 2 hours | 
| change in Mean Arterial blood pressure during pneumoperitoneum | 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 | from baseline to the end of pneumoperitoneum, an average of 2 hours | 
| change in Heart Rate during pneumoperitoneum | 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 | from baseline to the end of pneumoperitoneum, an average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure intubation | SBP will be noted at the induction. | Induction | 
| Diastolic Blood pressure intubation | DBP will be noted at the induction | Induction | 
| Mean Arterial blood pressure intubation | MAP will be noted at the induction. | Induction | 
| heart rate intubation | HR will be noted at the induction. | Induction | 
| Post operative sedation | Modified Ramsey score use for sedation, it consist of 1-6 where 6 indicates worst(no response) and 6 indicates good response From completion of surgery to 30 minutes post operatively | every 5 minutes, up to 30minutes | 
| Post operative analgesia | Visual analogue scale From completion of surgery to 30 minutes post operatively (0 no pain, 10 wost pain) | every 5 minutes, up to 30minutes | 
| Complication | bradycardia, tachycardia, hypertension and hypotension | every 5 minutes from induction, up to 30 minutes post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attenuation, dexmedetomidine, pneumoperitoneum, hemodynamic stability, pressor response, laryngoscopy response, intubation response