Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 5:28 AM
Study NCT ID:
NCT05813106
Status:
UNKNOWN
Last Update Posted:
2023-04-14
First Post:
2023-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Dexmedetomidine for Emergence Delirium in Pediatric Patient
Sponsor:
Security Forces Hospital
Organization:
Study Overview
Official Title:
Effect of Fixed Dose Intravenous Dexmedetomidine on Emergence Delirium After General Anesthesia for a Surgery in Pediatric Patient
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
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 0.15 mcg/kg to 2 mcg/kg 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 0.2 mcg/kg 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 0.15 mcg/kg to 2 mcg/kg 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 0.2 mcg/kg 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 0.15 mcg/kg to 2 mcg/kg 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 0.2 mcg/kg dexmedetomidine in prevention of emergence delirium in pediatric patients undergoing general anesthesia.
Study Oversight
Has Oversight DMC:
True
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?: