Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631534
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Dexmedetomidine Supplementation to General Anaesthesia in Paediatric Transcatheter Closure of Atrial Septal Defect
Status:
RECRUITING
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:
The aim of this randomized trial is to determine efficacy of dexmedetomidine in improving quality of recovery in pediatric patients undergoing interventional catheter closure of ASD while maintaining the hemodynamic parameters Additionally he stress reducing effects of dexmedetomidine will be investigated in this population
The main questions it aims to answer are
Does Dexmedetomidine maintain stable hemodynamics in pediatric patients undergoing transcatheter ASD Closure while improving their quality of recovery
Does dexmedetomidine prolong duration of recovery and time to extubation in pediatric patients
Does dexmedetomidine exert stress reducing properties in this population
Participants will
Either be administered Dexmedetomidine in a loadingmaintenance regimen or a placebo with hemodynamics being monitored at the baseline intraoperatively and postoperatively with recovery time and quality of recovery especially emergence delirium being monitored Stress hormone levels will be sampled at baseline and postoperatively
The main questions it aims to answer are
Does Dexmedetomidine maintain stable hemodynamics in pediatric patients undergoing transcatheter ASD Closure while improving their quality of recovery
Does dexmedetomidine prolong duration of recovery and time to extubation in pediatric patients
Does dexmedetomidine exert stress reducing properties in this population
Participants will
Either be administered Dexmedetomidine in a loadingmaintenance regimen or a placebo with hemodynamics being monitored at the baseline intraoperatively and postoperatively with recovery time and quality of recovery especially emergence delirium being monitored Stress hormone levels will be sampled at baseline and postoperatively
Detailed Description:
Atrial Septal Defect ASD is one of the most common congenital anomalies in pediatric and even in adult population it is associated with a left-to-right shunt resulting in right ventricular RV volume overload and increase in pulmonary blood flow eventually culmination in right ventricular heart failure RVHF and pulmonary hypertension
Percutaneous closure of ASD was devised nearly a half century ago and now constitutes a viable alternative to the standard approach of surgical closure Anesthesia for pediatric patients undergoing percutaneous closure involves a spectrum from sedation to general anesthesia using a variety of drugs according to institutional protocol
Stress response represents the sum of metabolic nd hormonal perturbations initiated by the hypothalamo-pituitary-adrenal axis in response to the surgical stimulus
Dexmedetomidine is an α2-adrenoreceptor agonist possessing stress ameliorating effects exerted on the central sympathetic outflow It can be used either alone in sedation or as supplementation to general anesthesia It possesses a remarkable hemodynamic stability profile and due to its prolonged duration of action it plays a significant role in reducing emergence delirium
This study aims at evaluating utility of dexmedetomidine as a supplementary agent to general anesthesia on hemodynamic stability cardiac output reduction of pediatric emergence delirium and stress hormone levels in pediatric patients undergoing transcatheter closure of ASD
Percutaneous closure of ASD was devised nearly a half century ago and now constitutes a viable alternative to the standard approach of surgical closure Anesthesia for pediatric patients undergoing percutaneous closure involves a spectrum from sedation to general anesthesia using a variety of drugs according to institutional protocol
Stress response represents the sum of metabolic nd hormonal perturbations initiated by the hypothalamo-pituitary-adrenal axis in response to the surgical stimulus
Dexmedetomidine is an α2-adrenoreceptor agonist possessing stress ameliorating effects exerted on the central sympathetic outflow It can be used either alone in sedation or as supplementation to general anesthesia It possesses a remarkable hemodynamic stability profile and due to its prolonged duration of action it plays a significant role in reducing emergence delirium
This study aims at evaluating utility of dexmedetomidine as a supplementary agent to general anesthesia on hemodynamic stability cardiac output reduction of pediatric emergence delirium and stress hormone levels in pediatric patients undergoing transcatheter closure of ASD
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