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

Delirium Clinical Trial

Official title:

Dexmedetomidine Infusion Versus Ketofol Infusion on The Incidence of Emergence Delirium in Children Undergoing Congenital Inguinal Hernia Repair: A Prospective Randomized Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786833
• Other study ID #: 36264MS43/1/23
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: October 20, 2023

Study information

• Verified date: March 2023
• Source: Tanta University
• Contact: Nada M Shaheen, Master
• Phone: +201006151953
• Email: nada169730_pg[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 20, 2023
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Delirium
• Dexmedetomidine
• Hernia
• Hernia, Inguinal

Intervention

Drug:
• Dexmedetomedine
Patients will receive intraoperative dexmedetomedine intravenous infusion at a dose of 0.2µg/kg/hour.
• Ketofol
Patients will receive intraoperative ketofol (1:10 ratio of ketamine-propofol mixture) intravenous infusion with %90 of Mcfarlan dose regiment. McFarlan dose regiments include 15 mg/kg/h infusion during 15 minutes, 13 mg/kg/h infusion during second 15 minutes, 11 mg/kg/h infusion from half to 1 and 10 mg/kg/h from 1 to 2 hours.
• isotonic saline 0.9%
Patients will receive intravenous infusion of equivalent volume of isotonic saline 0.9%.

Locations

Country	Name	City	State
Egypt	Nada Maged Shaheen	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative emergence delirium	Assessment of delirium using Pediatric Anesthesia Emergence Delirium (PAED) will be performed on arrival at the Post Anesthesia Care Unit (PACU)	5 -15 minutes