Clinical trial NCT04646317: Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy
Official title: To Observe the Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hypertension
Laparoscopic Cholecystectomy
Keywords: Attenuation
dexmedetomidine
pneumoperitoneum
hemodynamic stability
pressor response
laryngoscopy response
intubation response
Lead sponsor: Dr. Ruth K.M. Pfau Civil Hospital, Karachi
Sponsor class: OTHER_GOV
First posted: 2020-11-27
Enrollment: 44
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised control trial
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Systolic blood pressure during pneumoperitoneum
timeFrame: From baseline to the end of pneumoperitonium, an average of 2 hours
measure: change in Diastolic blood pressure during pneumoperitoneum
timeFrame: from baseline to the end of pneumoperitoneum, an average of 2 hours
measure: change in Mean Arterial blood pressure during pneumoperitoneum
timeFrame: from baseline to the end of pneumoperitoneum, an average of 2 hours
measure: change in Heart Rate during pneumoperitoneum
timeFrame: from baseline to the end of pneumoperitoneum, an average of 2 hours
Secondary outcomes:
measure: Systolic blood pressure intubation
timeFrame: Induction
measure: Diastolic Blood pressure intubation
timeFrame: Induction
measure: Mean Arterial blood pressure intubation
timeFrame: Induction
measure: heart rate intubation
timeFrame: Induction
measure: Post operative sedation
timeFrame: every 5 minutes, up to 30minutes
measure: Post operative analgesia
timeFrame: every 5 minutes, up to 30minutes
measure: Complication
timeFrame: every 5 minutes from induction, up to 30 minutes post procedure
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr. Ruth K.M Pfau Civil Hospital Dow university of health sciences
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Muhammad Imran, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Dow University of Health Sciences
name: Hanya Javaid, FCPS
role: PRINCIPAL_INVESTIGATOR
References: