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

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05786833

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dexmedetomidine Ketofol Delirium Hernia	Drug: Dexmedetomedine Drug: Ketofol Drug: isotonic saline 0.9%	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 20, 2023

Anticipated Primary Completion Date :

Oct 20, 2023

Anticipated Study Completion Date :

Oct 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexmedetomidine Group	Drug: Dexmedetomedine Patients will receive intraoperative dexmedetomedine intravenous infusion at a dose of 0.2µg/kg/hour.
Active Comparator: Ketofol Group	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.
Placebo Comparator: Control Group	Drug: isotonic saline 0.9% Patients will receive intravenous infusion of equivalent volume of isotonic saline 0.9%.

Arm

Intervention/Treatment

Active Comparator: Dexmedetomidine Group

Drug: Dexmedetomedine

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

Active Comparator: Ketofol Group

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.

Placebo Comparator: Control Group

Drug: isotonic saline 0.9%

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

Outcome Measures

Primary Outcome Measures

Incidence of postoperative emergence delirium [5 -15 minutes]
Assessment of delirium using Pediatric Anesthesia Emergence Delirium (PAED) will be performed on arrival at the Post Anesthesia Care Unit (PACU)

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 5 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nada Maged Shaheen	Tanta	El-Gharbia	Egypt	31527

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT05786833

Other Study ID Numbers:

36264MS43/1/23

First Posted:

Mar 28, 2023

Last Update Posted:

Mar 28, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Delirium

Hernia

Hernia, Inguinal

Study Results

No Results Posted as of Mar 28, 2023