Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy
NCT ID: NCT04646317
Last Updated: 2020-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
44 participants
INTERVENTIONAL
2020-12-30
2021-03-02
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Dexmedetomidine
Dexmedetomidine infusion four 50 ml syringes containing 1 microgram per ml dexmedetomidine
Dexmedetomidine injection
Infusion of dexmedetomidine will be prepared in Four syringes of 50ml containing dexmedetomidine in concentration of 1 microgram per millilitre.
normaL SALINE 0.9%
Four 50 ml syringes of .9 % Normal SALINE
Normal Saline
0.9% as placebo
Interventions
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Dexmedetomidine injection
Infusion of dexmedetomidine will be prepared in Four syringes of 50ml containing dexmedetomidine in concentration of 1 microgram per millilitre.
Normal Saline
0.9% as placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA II and III
Exclusion Criteria
* 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
17 Years
70 Years
ALL
No
Sponsors
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Dr. Ruth K.M. Pfau Civil Hospital, Karachi
OTHER_GOV
Responsible Party
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Muhammad Imran Riasat
Senior Registerar
Principal Investigators
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Muhammad Imran, FCPS
Role: PRINCIPAL_INVESTIGATOR
Dow University of Health Sciences
Hanya Javaid, FCPS
Role: PRINCIPAL_INVESTIGATOR
Dow University of Health Sciences
Locations
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Dr. Ruth K.M Pfau Civil Hospital Dow university of health sciences
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Muhammad Imran, FCPS
Role: primary
Hanya Javaid, FCPS
Role: backup
Other Identifiers
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PfauCHKarachi
Identifier Type: -
Identifier Source: org_study_id