Dexmedetomidine vs Ketofol on Delirium in Children Undergoing Congenital Inguinal Hernia Repair

Tanta University

Status: Enrolling

Conditions: Delirium; Dexmedetomidine; Hernia; Ketofol

Treatments: Drug: Ketofol; Drug: isotonic saline 0.9%; Drug: Dexmedetomedine

Study type: Interventional

Funder types: Other

Identifiers

NCT05786833

36264MS43/1/23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 60 children aged from 2 to 5 years
• presented with congenital inguinal hernia
• the American Society of Anaesthesiologists classification ASA I-II.

Exclusion criteria

• Past medical history of mental illness or neurological illness.
• Renal or hepatic diseases.
• Severe hearing or visual impairment which may interfere with communication and physical decline.
• Congenital heart disease.
• History of allergy to any of the study drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Dexmedetomidine Group

Active Comparator group

Treatment:

Drug: Dexmedetomedine

Ketofol Group

Active Comparator group

Treatment:

Drug: Ketofol

Control Group

Placebo Comparator group

Treatment:

Drug: isotonic saline 0.9%