Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649487
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Effect of Hypertension on Hemodynamics in the Prone Position
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Investigation of the Effect of Hypertension on Hemodynamics in the Prone Position
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Long-term use of antihypertensive drugs in patients diagnosed with hypertension may cause sharp fluctuations in the patients hemodynamic values such as blood pressure during anesthesia Low blood pressure that occurs during surgery may cause serious organ failure and even death especially in patients in the prone position
These conditions resulting from hypotension increase with prolonged exposure to hypotension Therefore it is very important to predict and prevent hypotension in spinal surgery
In patients with hypertension the prone position may cause some hemodynamic changes compared to those without comorbidities Therefore in this study researchers planned to investigate the changes in some hemodynamic values in patients with hypertension and without comorbidities who were scheduled for spinal surgery
These conditions resulting from hypotension increase with prolonged exposure to hypotension Therefore it is very important to predict and prevent hypotension in spinal surgery
In patients with hypertension the prone position may cause some hemodynamic changes compared to those without comorbidities Therefore in this study researchers planned to investigate the changes in some hemodynamic values in patients with hypertension and without comorbidities who were scheduled for spinal surgery
Detailed Description:
The number of spine surgeries has increased in recent years due to degenerative diseases of the spine and age Lumbar spine surgery is a surgery performed in the prone position Changing the patients position from supine to prone may cause a decrease in cardiac output arterial pressure and tissue perfusion due to the decrease in the preload of the heart In addition to the decrease in venous return due to increased intra-abdominal pressure left ventricular compliance may be impaired due to increased thoracic pressure All these changes may cause decreased cardiac output and systemic hypotension These changes may be more pronounced especially with the prone position accompanied by anesthesia This situation is thought to be due to the fact that anesthetic drugs cause direct hypotension as well as impairing reflex responses to hypotension such as the sympathetic system Perioperative cardiac complications are the main causes of mortality after non-cardiac surgery Intraoperative hypotension especially in patients in the prone position has been shown to be significantly associated with clinical outcomes such as spinal cord ischemia and postoperative vision loss and may lead to serious complications Therefore optimization of hemodynamic variables is an integral part of perioperative care to reduce postoperative mortality and morbidity during surgeries that require patients to be placed in the prone position such as vertebral surgery
More than 280 million surgeries are performed worldwide each year and approximately one-third of these patients use antihypertensive agents before surgery It has been reported that hypertension is associated with hypotension especially after induction in patients receiving general anesthesia Therefore it has been stated that perioperative management of patients receiving antihypertensive drugs is especially important Patients diagnosed with preoperative hypertension have been associated with increased risk of surgical bleeding stroke and cardiovascular complications Long-term use of antihypertensive drugs in hypertensive patients may cause autonomic nerve dysfunction leading to perioperative hypovolemia decreased tolerance to postural changes and sharp fluctuations in circulation Therefore maintaining hemodynamic stability in hypertensive patients receiving general anesthesia may be difficult The change in prone position required for vertebral surgery may be associated with a high risk of developing hypotension due to decreased venous return from inferior vena cava compression and increased intrathoracic pressure In awake patients hypotension caused by changes in position is prevented by baroreceptor reflex and sympathetic activation whereas in anesthetized patients anesthetic drugs may block these compensatory mechanisms potentially increasing the incidence of hypotension associated with postural change It has been reported that the incidence of hypotension associated with the change from supine to prone position under general anesthesia is approximately three times higher than in awake patients However there are also studies reporting that perioperative hemodynamic changes in patients with hypertension are similar to those without additional comorbidities MostCare Vytech Health Vygon Padova Italy is a self-calibrating device based on continuous analysis of the systolic and diastolic phases of the arterial waveform via an intraarterial catheter In short this monitoring method provides valuable information in terms of cardiac and vascular functions and intravascular volume as well as close monitoring of blood pressure It is an important guide in the rapid recognition of etiology and treatment of hemodynamic changes Spine surgery is mostly performed in the prone position and under general anesthesia Both general anesthesia and prone position can cause significant changes in the patients hemodynamics However there are limited studies on hemodynamic changes during anesthesia of patients diagnosed with hypertension and their results are contradictory In this study researchers aimed to investigate the effect of hypertension on cardiovascular and hemodynamic changes in the prone position
More than 280 million surgeries are performed worldwide each year and approximately one-third of these patients use antihypertensive agents before surgery It has been reported that hypertension is associated with hypotension especially after induction in patients receiving general anesthesia Therefore it has been stated that perioperative management of patients receiving antihypertensive drugs is especially important Patients diagnosed with preoperative hypertension have been associated with increased risk of surgical bleeding stroke and cardiovascular complications Long-term use of antihypertensive drugs in hypertensive patients may cause autonomic nerve dysfunction leading to perioperative hypovolemia decreased tolerance to postural changes and sharp fluctuations in circulation Therefore maintaining hemodynamic stability in hypertensive patients receiving general anesthesia may be difficult The change in prone position required for vertebral surgery may be associated with a high risk of developing hypotension due to decreased venous return from inferior vena cava compression and increased intrathoracic pressure In awake patients hypotension caused by changes in position is prevented by baroreceptor reflex and sympathetic activation whereas in anesthetized patients anesthetic drugs may block these compensatory mechanisms potentially increasing the incidence of hypotension associated with postural change It has been reported that the incidence of hypotension associated with the change from supine to prone position under general anesthesia is approximately three times higher than in awake patients However there are also studies reporting that perioperative hemodynamic changes in patients with hypertension are similar to those without additional comorbidities MostCare Vytech Health Vygon Padova Italy is a self-calibrating device based on continuous analysis of the systolic and diastolic phases of the arterial waveform via an intraarterial catheter In short this monitoring method provides valuable information in terms of cardiac and vascular functions and intravascular volume as well as close monitoring of blood pressure It is an important guide in the rapid recognition of etiology and treatment of hemodynamic changes Spine surgery is mostly performed in the prone position and under general anesthesia Both general anesthesia and prone position can cause significant changes in the patients hemodynamics However there are limited studies on hemodynamic changes during anesthesia of patients diagnosed with hypertension and their results are contradictory In this study researchers aimed to investigate the effect of hypertension on cardiovascular and hemodynamic changes in the prone position
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None