Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05813106
Status:
RECRUITING
Last Update Posted:
2023-04-14
First Post:
2023-02-21
Brief Title:
Intravenous Dexmedetomidine for Emergence Delirium in Pediatric Patient
Sponsor:
Security Forces Hospital
Organization:
Security Forces Hospital
Study Overview
Official Title:
Effect of Fixed Dose Intravenous Dexmedetomidine on Emergence Delirium After General Anesthesia for a Surgery in Pediatric Patient
Status:
RECRUITING
Status Verified Date:
2023-04
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:
Various pharmacological interventions in peri-operative period have been used in literature to prevent ED which include use of propofol fentanyl ketamine clonidine midazolam and dexmedetomidine etc 5 Dexmedetomidine is a potent highly selective alpha-2 agonist Its effect on the receptors in brain results in sedation resembling non-REM sleep with minimal respiratory depression 6 It has been used as continuous infusion or as fixed dose in the range between 015 mcgkg to 2 mcgkg to prevent ED in children 7 8 9 Higher doses result in better prevention of ED at the expense of more hemodynamic disturbances and longer PACU stay 9 while lower doses were not as effective 7 The aim of this study was to investigate the role of fixed dose of 02 mcgkg dexmedetomidine in prevention of emergence delirium in pediatric patients undergoing general anesthesia
Detailed Description:
Emergence delirium ED is an altered state of consciousness that usually occurs within 45 minutes after cessation of anesthesia It typically presents as disorientation averted eyes or staring psychomotor agitation and non-purposeful resistive movements like pulling kicking or flailing 1 2 ED can result in potential risk of bodily harm to patient or healthcare staffs prolonged PACU post-anesthesia care unit stay and postoperative maladaptive changes including temper tantrums attention seeking sleep alterations and bed wetting in children 2
Risk factors for ED include preoperative anxiety and confusion psychological immaturity and use of various medications peri-operatively 2 3 The incidence of ED varies by age of patient anesthesia technique type of surgeries pain and also by choice of tool to diagnose ED It occurs two to three more commonly in children as compared to adults Scientific literature suggest the incidence of ED in the range between 20 -80 in pediatric anesthesia practice 4
Various pharmacological interventions in peri-operative period have been used in literature to prevent ED which include use of propofol fentanyl ketamine clonidine midazolam and dexmedetomidine etc 5 Dexmedetomidine is a potent highly selective alpha-2 agonist Its effect on the receptors in brain results in sedation resembling non-REM sleep with minimal respiratory depression 6 It has been used as continuous infusion or as fixed dose in the range between 015 mcgkg to 2 mcgkg to prevent ED in children 7 8 9 Higher doses result in better prevention of ED at the expense of more hemodynamic disturbances and longer PACU stay 9 while lower doses were not as effective 7 The aim of this study was to investigate the role of fixed dose of 02 mcgkg dexmedetomidine in prevention of emergence delirium in pediatric patients undergoing general anesthesia
Risk factors for ED include preoperative anxiety and confusion psychological immaturity and use of various medications peri-operatively 2 3 The incidence of ED varies by age of patient anesthesia technique type of surgeries pain and also by choice of tool to diagnose ED It occurs two to three more commonly in children as compared to adults Scientific literature suggest the incidence of ED in the range between 20 -80 in pediatric anesthesia practice 4
Various pharmacological interventions in peri-operative period have been used in literature to prevent ED which include use of propofol fentanyl ketamine clonidine midazolam and dexmedetomidine etc 5 Dexmedetomidine is a potent highly selective alpha-2 agonist Its effect on the receptors in brain results in sedation resembling non-REM sleep with minimal respiratory depression 6 It has been used as continuous infusion or as fixed dose in the range between 015 mcgkg to 2 mcgkg to prevent ED in children 7 8 9 Higher doses result in better prevention of ED at the expense of more hemodynamic disturbances and longer PACU stay 9 while lower doses were not as effective 7 The aim of this study was to investigate the role of fixed dose of 02 mcgkg dexmedetomidine in prevention of emergence delirium in pediatric patients undergoing general anesthesia
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