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

NCT ID: NCT05786833

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2023-10-20

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.

Conditions

Dexmedetomidine; Ketofol; Delirium; Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dexmedetomidine Group

Group Type: ACTIVE_COMPARATOR

Dexmedetomedine

Intervention Type: DRUG

Patients will receive intraoperative dexmedetomedine intravenous infusion at a dose of 0.2µg/kg/hour.

Ketofol Group

Group Type: ACTIVE_COMPARATOR

Ketofol

Intervention Type: DRUG

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.

Control Group

Group Type: PLACEBO_COMPARATOR

isotonic saline 0.9%

Intervention Type: DRUG

Patients will receive intravenous infusion of equivalent volume of isotonic saline 0.9%.

Interventions

Dexmedetomedine

Patients will receive intraoperative dexmedetomedine intravenous infusion at a dose of 0.2µg/kg/hour.

Intervention Type: DRUG

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.

Intervention Type: DRUG

isotonic saline 0.9%

Patients will receive intravenous infusion of equivalent volume of isotonic saline 0.9%.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Nada Maged Shaheen

Resident of Anesthesia, Surgical Intensive Care and Pain Management ,Faculty of medicine ,Tanta University, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nada Maged Shaheen

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nada M Shaheen, Master

Role: CONTACT

nada169730_pg@med.tanta.edu.eg

+201006151953 ext. 139

Facility Contacts

Nada M Shaheen, Master

Role: primary

nada169730_pg@med.tanta.edu.eg

+201006151953 ext. 139

Other Identifiers

36264MS43/1/23

Identifier Type: -

Identifier Source: org_study_id