Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04646317
• Other study ID #: PfauCHKarachi
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 30, 2020
• Est. completion date: March 2, 2021

Study information

• Verified date: December 2020
• Source: Dr. Ruth K.M. Pfau Civil Hospital, Karachi
• Contact: Muhammad Imran, FCPS
• Phone: +923342947181
• Email: dr.imranriasat[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: March 2, 2021
• Est. primary completion date: March 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Laparoscopic Cholecystectomy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Pakistan	Dr. Ruth K.M Pfau Civil Hospital Dow university of health sciences	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Ruth K.M. Pfau Civil Hospital, Karachi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Systolic blood pressure intubation	SBP will be noted at the induction.	Induction
Secondary	Diastolic Blood pressure intubation	DBP will be noted at the induction	Induction
Secondary	Mean Arterial blood pressure intubation	MAP will be noted at the induction.	Induction
Secondary	heart rate intubation	HR will be noted at the induction.	Induction
Secondary	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
Secondary	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
Secondary	Complication	bradycardia, tachycardia, hypertension and hypotension	every 5 minutes from induction, up to 30 minutes post procedure