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

NCT05786833 | Unknown

• 1 other identifier: 36264MS43/1/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine; Ketofol; Delirium; Hernia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Dexmedetomidine Group

ACTIVE COMPARATOR

Drug: Dexmedetomedine

Ketofol Group

ACTIVE COMPARATOR

Drug: Ketofol

Control Group

PLACEBO COMPARATOR

Drug: isotonic saline 0.9%

Interventions

Dexmedetomedine DRUG

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

Dexmedetomidine Group

Ketofol 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.

Ketofol Group

isotonic saline 0.9% DRUG

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

Control Group

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Nada Maged Shaheen

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Delirium; Hernia

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical

Central Study Contacts

Nada M Shaheen, Master

CONTACT

+201006151953; nada169730_pg@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain Management ,Faculty of medicine ,Tanta University, Egypt

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 28, 2023
• Study Start: March 20, 2023
• Primary Completion: October 20, 2023
• Study Completion: October 20, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: one year

Locations

EG (1)