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Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy

Primary Purpose

Hypertension, Laparoscopic Cholecystectomy

Status
Unknown status
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Dexmedetomidine injection
Normal Saline
Sponsored by
Dr. Ruth K.M. Pfau Civil Hospital, Karachi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Attenuation, dexmedetomidine, pneumoperitoneum, hemodynamic stability, pressor response, laryngoscopy response, intubation response

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Ruth K.M Pfau Civil Hospital Dow university of health sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dexmedetomidine

normaL SALINE 0.9%

Arm Description

Dexmedetomidine infusion four 50 ml syringes containing 1 microgram per ml dexmedetomidine

Four 50 ml syringes of .9 % Normal SALINE

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Systolic blood pressure intubation
SBP will be noted at the induction.
Diastolic Blood pressure intubation
DBP will be noted at the induction
Mean Arterial blood pressure intubation
MAP will be noted at the induction.
heart rate intubation
HR will be noted at the 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
Post operative analgesia
Visual analogue scale From completion of surgery to 30 minutes post operatively (0 no pain, 10 wost pain)
Complication
bradycardia, tachycardia, hypertension and hypotension

Full Information

First Posted
October 24, 2020
Last Updated
December 21, 2020
Sponsor
Dr. Ruth K.M. Pfau Civil Hospital, Karachi
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1. Study Identification

Unique Protocol Identification Number
NCT04646317
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 30, 2020 (Anticipated)
Primary Completion Date
March 2, 2021 (Anticipated)
Study Completion Date
March 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Ruth K.M. Pfau Civil Hospital, Karachi

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Laparoscopic Cholecystectomy
Keywords
Attenuation, dexmedetomidine, pneumoperitoneum, hemodynamic stability, pressor response, laryngoscopy response, intubation response

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomised control trial
Masking
ParticipantCare Provider
Masking Description
Patients and care provider do not know about the interventions
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine
Arm Type
Experimental
Arm Description
Dexmedetomidine infusion four 50 ml syringes containing 1 microgram per ml dexmedetomidine
Arm Title
normaL SALINE 0.9%
Arm Type
Placebo Comparator
Arm Description
Four 50 ml syringes of .9 % Normal SALINE
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine injection
Other Intervention Name(s)
dexmedetomidine
Intervention Description
Infusion of dexmedetomidine will be prepared in Four syringes of 50ml containing dexmedetomidine in concentration of 1 microgram per millilitre.
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
0.9% as placebo
Primary Outcome Measure Information:
Title
Change in Systolic blood pressure during pneumoperitoneum
Description
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
Time Frame
From baseline to the end of pneumoperitonium, an average of 2 hours
Title
change in Diastolic blood pressure during pneumoperitoneum
Description
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
Time Frame
from baseline to the end of pneumoperitoneum, an average of 2 hours
Title
change in Mean Arterial blood pressure during pneumoperitoneum
Description
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
Time Frame
from baseline to the end of pneumoperitoneum, an average of 2 hours
Title
change in Heart Rate during pneumoperitoneum
Description
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
Time Frame
from baseline to the end of pneumoperitoneum, an average of 2 hours
Secondary Outcome Measure Information:
Title
Systolic blood pressure intubation
Description
SBP will be noted at the induction.
Time Frame
Induction
Title
Diastolic Blood pressure intubation
Description
DBP will be noted at the induction
Time Frame
Induction
Title
Mean Arterial blood pressure intubation
Description
MAP will be noted at the induction.
Time Frame
Induction
Title
heart rate intubation
Description
HR will be noted at the induction.
Time Frame
Induction
Title
Post operative sedation
Description
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
Time Frame
every 5 minutes, up to 30minutes
Title
Post operative analgesia
Description
Visual analogue scale From completion of surgery to 30 minutes post operatively (0 no pain, 10 wost pain)
Time Frame
every 5 minutes, up to 30minutes
Title
Complication
Description
bradycardia, tachycardia, hypertension and hypotension
Time Frame
every 5 minutes from induction, up to 30 minutes post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Imran, FCPS
Phone
+923342947181
Email
dr.imranriasat@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hanya Javaid, FCPS
Phone
+923452424442
Email
drhanyajavaidi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Imran, FCPS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hanya Javaid, FCPS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Ruth K.M Pfau Civil Hospital Dow university of health sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75520
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Imran, FCPS
Phone
+923342947181
Email
dr.imranriasat@gmail.com
First Name & Middle Initial & Last Name & Degree
Hanya Javaid, FCPS
Phone
+923452424442
Email
drhanyajavaidi@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy

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