Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT05786833
Status:
UNKNOWN
Last Update Posted:
2023-04-05
First Post:
2023-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexmedetomidine vs Ketofol on Delirium in Children Undergoing Congenital Inguinal Hernia Repair
Sponsor:
Tanta University
Organization:
Study Overview
Official Title:
Dexmedetomidine Infusion Versus Ketofol Infusion on The Incidence of Emergence Delirium in Children Undergoing Congenital Inguinal Hernia Repair: A Prospective Randomized Trial.
Status:
UNKNOWN
Status Verified Date:
2023-03
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:
The aim of this study is to compare the effect of dexmedetomidine versus ketofol on the incidence of the emergence delirium in children undergoing congenital inguinal hernia repair.
Detailed Description:
Emergence delirium (ED) is a disturbance in a child's awareness or attention to his/her environment with disorientation and perceptual alterations including hypersensitivity to stimuli and hyperactive motor behaviour in the immediate post anesthesia period.
Propofol is a non-opioid, non-barbiturate, sedative-hypnotic agent with rapid onset and short duration of action \[12\]. Ketamine is a phencyclidine derivative classified as a dissociative sedative that provides analgesia and amnesia.
Combination of ketamine with propofol reduces the sedative dose of propofol. The complementary effects of this combination are supposed to produce lower toxicity compared to each drug alone through decreasing required doses. Ketofol; mixed ketamine and propofol has been shown to be effective in emergency room for procedural sedation and for induction for rapid sequence intubation \[13,14\]. This combination is also effective to prevent ED in pediatric patients undergoing simple surgical procedural in addition to the advantage of better hemodynamic stability.
Dexmedetomidine is a highly selective, alpha2-adrenergic receptor agonist that has been widely used for adult anesthesia and as a sedative in intensive care units. Dexmedetomidine is safe in children due to its hypnotic, analgesic, sedative, and anxiolytic effects. it has been shown to improve intraoperative hemodynamic stability, minimize responses to stimuli, and reduce the need for other anesthetic agents.
Propofol is a non-opioid, non-barbiturate, sedative-hypnotic agent with rapid onset and short duration of action \[12\]. Ketamine is a phencyclidine derivative classified as a dissociative sedative that provides analgesia and amnesia.
Combination of ketamine with propofol reduces the sedative dose of propofol. The complementary effects of this combination are supposed to produce lower toxicity compared to each drug alone through decreasing required doses. Ketofol; mixed ketamine and propofol has been shown to be effective in emergency room for procedural sedation and for induction for rapid sequence intubation \[13,14\]. This combination is also effective to prevent ED in pediatric patients undergoing simple surgical procedural in addition to the advantage of better hemodynamic stability.
Dexmedetomidine is a highly selective, alpha2-adrenergic receptor agonist that has been widely used for adult anesthesia and as a sedative in intensive care units. Dexmedetomidine is safe in children due to its hypnotic, analgesic, sedative, and anxiolytic effects. it has been shown to improve intraoperative hemodynamic stability, minimize responses to stimuli, and reduce the need for other anesthetic agents.
Study Oversight
Has Oversight DMC:
False
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?: