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

Primary Purpose

Dexmedetomidine, Ketofol, Delirium

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomedine
Ketofol
isotonic saline 0.9%
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dexmedetomidine

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Nada Maged ShaheenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Dexmedetomidine Group

Ketofol Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
March 10, 2023
Last Updated
March 31, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05786833
Brief Title
Dexmedetomidine vs Ketofol on Delirium in Children Undergoing Congenital Inguinal Hernia Repair
Official Title
Dexmedetomidine Infusion Versus Ketofol Infusion on The Incidence of Emergence Delirium in Children Undergoing Congenital Inguinal Hernia Repair: A Prospective Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
October 20, 2023 (Anticipated)
Study Completion Date
October 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dexmedetomidine, Ketofol, Delirium, Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexmedetomidine Group
Arm Type
Active Comparator
Arm Title
Ketofol Group
Arm Type
Active Comparator
Arm Title
Control Group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomedine
Intervention Description
Patients will receive intraoperative dexmedetomedine intravenous infusion at a dose of 0.2µg/kg/hour.
Intervention Type
Drug
Intervention Name(s)
Ketofol
Intervention Description
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
Intervention Name(s)
isotonic saline 0.9%
Intervention Description
Patients will receive intravenous infusion of equivalent volume of isotonic saline 0.9%.
Primary Outcome Measure Information:
Title
Incidence of postoperative emergence delirium
Description
Assessment of delirium using Pediatric Anesthesia Emergence Delirium (PAED) will be performed on arrival at the Post Anesthesia Care Unit (PACU)
Time Frame
5 -15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nada M Shaheen, Master
Phone
+201006151953
Ext
139
Email
nada169730_pg@med.tanta.edu.eg
Facility Information:
Facility Name
Nada Maged Shaheen
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nada M Shaheen, Master
Phone
+201006151953
Ext
139
Email
nada169730_pg@med.tanta.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon reasonable request from the principal investigator
IPD Sharing Time Frame
one year

Learn more about this trial

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

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