Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535230
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Anesthesia Induction with the Target-controlled Infusion of Propofol in High-risk Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Does Induction of Anesthesia with Target-controlled Propofol Infusion Reduce the Risk of Post-induction Hypotension in High-risk Patients
Status:
RECRUITING
Status Verified Date:
2024-09
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:
The purpose of this study is to compare the risk of hypotension following induction of anesthesia in high-risk patients American Society of Anesthesiologists risk scores III and IV using target-controlled infusion TCI of propofol versus standard manual induction of anesthesia Our previously published study compared TCI and manual induction of anesthesia in a general patient population and found that hypotension developed less with TCI induction This study is a continuation of the other study and will be conducted in high-risk patients
Detailed Description:
Hypotension after induction of anesthesia is a very common condition Despite well-known risk factors and advanced monitoring techniques hypotension after induction of anesthesia occurs in approximately 30 of patients The risk of hypotension increases in patients with comorbidities such as hypertension heart failure renal failure diabetes mellitus patients with high ASA American Society of Anesthesiologists risk scores geriatric patients patients undergoing major surgery and patients with prolonged fasting periods In order to prevent post-induction hypotension the risk factors of the patient such as comorbidities and surgery cannot be changed but this risk can be reduced with different anesthesia induction techniques
Since anesthetic agents are administered at a fixed dose and rate adjusted according to the patients weight in standard anesthesia induction it may cause hypotension in patients with low cardiovascular performance
The fall in blood pressure is due to a decrease in systemic vascular resistance or cardiac output and may be increased by the concomitant use of other drugs such as remifentanil Target-controlled infusions TCI have been developed to overcome these drawbacks of standard anesthesia induction and maintenance TCI systems enable titration of anesthetic agents according to the needs of each patient by using pharmacokinetic models through perfusers with special microprocessors With these features TCI can provide better control of hemodynamic variations during induction and maintenance of anesthesia Patients will undergo hemodynamic monitoring using the pressure analytic recording method PRAM The functional hemodynamic data provided by this monitoring technique will allow us to better analyze the causes and consequences of hypotension In this study investigators aimed to monitor and compare the hemodynamic effects of TCI induction and manual anesthesia induction through PRAM parameters by monitoring patients with high ASA scores before and after induction Investigators anticipate that these 2 technologies TCI and PRAM can provide a better hemodynamic profile in the high-risk patient group with high ASA scores thanks to the advanced monitoring provided to the patient in our anesthesia practice
Since anesthetic agents are administered at a fixed dose and rate adjusted according to the patients weight in standard anesthesia induction it may cause hypotension in patients with low cardiovascular performance
The fall in blood pressure is due to a decrease in systemic vascular resistance or cardiac output and may be increased by the concomitant use of other drugs such as remifentanil Target-controlled infusions TCI have been developed to overcome these drawbacks of standard anesthesia induction and maintenance TCI systems enable titration of anesthetic agents according to the needs of each patient by using pharmacokinetic models through perfusers with special microprocessors With these features TCI can provide better control of hemodynamic variations during induction and maintenance of anesthesia Patients will undergo hemodynamic monitoring using the pressure analytic recording method PRAM The functional hemodynamic data provided by this monitoring technique will allow us to better analyze the causes and consequences of hypotension In this study investigators aimed to monitor and compare the hemodynamic effects of TCI induction and manual anesthesia induction through PRAM parameters by monitoring patients with high ASA scores before and after induction Investigators anticipate that these 2 technologies TCI and PRAM can provide a better hemodynamic profile in the high-risk patient group with high ASA scores thanks to the advanced monitoring provided to the patient in our anesthesia practice
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