Ignite Creation Date:
2024-07-17 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464263
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-09
Brief Title:
Dexmedetomidine Versus Midazolam-Fentanyl for Analgesia and Sedation
Sponsor:
Egymedicalpedia
Organization:
Egymedicalpedia
Study Overview
Official Title:
Comparative Study Between Dexmedetomidine Versus Midazolam-Fentanyl for Analgesia and Sedation After Adult Valvular Cardiac Surgeries a Prospective Randomized Blinded Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
Postoperative sedation is an essential component in recovery of the patient undergoing cardiac surgery It facilitates the patients unawareness of the environment as well as reduce the discomfort and anxiety caused by surgery intubation mechanical ventilation suction and physiotherapy
Despite the advances in anesthesia and surgical techniques the duration of mechanical ventilation MV may be prolonged after cardiac surgery due to the classic high-dose narcotic-based cardiac anesthesia
Despite the advances in anesthesia and surgical techniques the duration of mechanical ventilation MV may be prolonged after cardiac surgery due to the classic high-dose narcotic-based cardiac anesthesia
Detailed Description:
In recent years fast-track extubation FTE protocols have been developed to reduce the long period of intubation and complications that may occur due to the long duration of MV Potential advantages of FTE protocols following surgery for congenital cardiac disease are reduced ventilator-associated pulmonary complications and the negative effects of positive pressure ventilation reduced nosocomial infections postoperative atelectasis reduced requirements of sedatives and analgesic drugs early enteral feeding rapid patient mobilization and shorter intensive care unit ICU stay
The ideal analgesic-sedative agents would keep the patient comfortable without anxiety It would effectively provide adequate sedation but also allow neurologic evaluation of the patient ideally without stopping administration of the drug It would have minimal hemodynamic and respiratory depressant effects It also would have a rapid onset and offset of action without drug accumulation or active metabolites making it easily titratable and allowing rapid recovery with a prompt return to normal activity after discontinuation
Opioids and benzodiazepines are the most frequently used analgesic-sedative agents after cardiac surgery Although opioid can provide excellent analgesia the doses for effective pain relief may lead to undesirable side effects such as respiratory depression requiring prolonged MV hemodynamic instability tolerance and significant withdrawal symptoms that also delay patient recovery
Dexmedetomidine is a highly selective α2-adrenoreceptor agonist Presynaptic activation of α2-adrenoreceptors at sympathetic nerve endings inhibits catecholamine release The major effect of dexmedetomidine is maintaining sedation-analgesia without a respiratory depressant effect It has relatively few cardiovascular side effects and produces sleep-like sedation without narcosis or respiratory depression
Indeed current guidelines recommend lighter levels of sedation to manage ventilated patients preferably using nonbenzodiazepine sedatives Nevertheless there is currently no consistent recommendation regarding which nonbenzodiazepine sedative agents should be used
The ideal analgesic-sedative agents would keep the patient comfortable without anxiety It would effectively provide adequate sedation but also allow neurologic evaluation of the patient ideally without stopping administration of the drug It would have minimal hemodynamic and respiratory depressant effects It also would have a rapid onset and offset of action without drug accumulation or active metabolites making it easily titratable and allowing rapid recovery with a prompt return to normal activity after discontinuation
Opioids and benzodiazepines are the most frequently used analgesic-sedative agents after cardiac surgery Although opioid can provide excellent analgesia the doses for effective pain relief may lead to undesirable side effects such as respiratory depression requiring prolonged MV hemodynamic instability tolerance and significant withdrawal symptoms that also delay patient recovery
Dexmedetomidine is a highly selective α2-adrenoreceptor agonist Presynaptic activation of α2-adrenoreceptors at sympathetic nerve endings inhibits catecholamine release The major effect of dexmedetomidine is maintaining sedation-analgesia without a respiratory depressant effect It has relatively few cardiovascular side effects and produces sleep-like sedation without narcosis or respiratory depression
Indeed current guidelines recommend lighter levels of sedation to manage ventilated patients preferably using nonbenzodiazepine sedatives Nevertheless there is currently no consistent recommendation regarding which nonbenzodiazepine sedative agents should be used
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?:
None
Is an FDA AA801 Violation?:
None