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Clinical Trials/NCT05786833
NCT05786833
Recruiting
Not Applicable

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

Tanta University1 site in 1 country60 target enrollmentMarch 20, 2023

Overview

Phase
Not Applicable
Intervention
Dexmedetomedine
Conditions
Dexmedetomidine
Sponsor
Tanta University
Enrollment
60
Locations
1
Primary Endpoint
Incidence of postoperative emergence delirium
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 20, 2023
End Date
October 20, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nada Maged Shaheen

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

Tanta University

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.

Arms & Interventions

Dexmedetomidine Group

Intervention: Dexmedetomedine

Ketofol Group

Intervention: Ketofol

Control Group

Intervention: isotonic saline 0.9%

Outcomes

Primary Outcomes

Incidence of postoperative emergence delirium

Time Frame: 5 -15 minutes

Assessment of delirium using Pediatric Anesthesia Emergence Delirium (PAED) will be performed on arrival at the Post Anesthesia Care Unit (PACU)

Study Sites (1)

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