Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy

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

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

Study Overview

• Status: Unknown
• Conditions: Hypertension; Laparoscopic Cholecystectomy
• Intervention / Treatment: Drug: Dexmedetomidine injection; Drug: Normal Saline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Muhammad Imran, FCPS; Phone Number: +923342947181; Email: dr.imranriasat@gmail.com
• Study Contact Backup: Name: Hanya Javaid, FCPS; Phone Number: +923452424442; Email: drhanyajavaidi@gmail.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75520
      • Dr. Ruth K.M Pfau Civil Hospital Dow university of health sciences
      • Contact: Muhammad Imran, FCPS; Phone Number: +923342947181; Email: dr.imranriasat@gmail.com
      • Contact: Hanya Javaid, FCPS; Phone Number: +923452424442; Email: drhanyajavaidi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dr. Ruth K.M. Pfau Civil Hospital, Karachi
• Investigators: Principal Investigator: Muhammad Imran, FCPS, Dow University of Health Sciences; Principal Investigator: Hanya Javaid, FCPS, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): December 30, 2020
• Primary Completion (Anticipated): March 2, 2021
• Study Completion (Anticipated): March 2, 2021

Study Registration Dates

• First Submitted: October 24, 2020
• First Submitted That Met QC Criteria: November 22, 2020
• First Posted (Actual): November 27, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: dexmedetomidine; pneumoperitoneum; hemodynamic stability; Attenuation; pressor response; laryngoscopy response; intubation response
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: PfauCHKarachi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No