Ignite Creation Date:
2024-05-06 @ 3:28 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04646317
Status:
UNKNOWN
Last Update Posted:
2020-12-22
First Post:
2020-10-24
Brief Title:
Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy
Sponsor:
Dr Ruth KM Pfau Civil Hospital Karachi
Organization:
Dr Ruth KM Pfau Civil Hospital Karachi
Study Overview
Official Title:
To Observe the Hemodynamic Stability of Dexmedetomidine in Hypertensive Patients Undergoing Laparoscopic Cholecystectomy
Status:
UNKNOWN
Status Verified Date:
2020-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dexmedetomidine provides better hemodynamic stability to the patients with hypertension undergoing laparoscopic cholecystectomy
Detailed Description:
Laparoscopic surgeries form an essence of todays 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 α2α1 activity of dexmedetomidine is 16201 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
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 α2α1 activity of dexmedetomidine is 16201 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None