Dexmedetomidine Versus Ketamine Versus Magnesium Sulfate for the Prevention of Emergence Agitation Following Sevoflurane Induced Anesthesia in Cardiac Catheterization in Pediatrics : A Prospective, Double-blinded, Randomized Controlled Study.

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

Emergence agitation (EA) is a post-operative behavioral disturbance was first reported in early 1960s. EA is a term used to describe non purposeful restlessness and agitation, thrashing, crying or moaning, disorientation and incoherence during early stage of recovering from general anesthesia in children, especially those receiving sevoflurane. Generally, the incidence of EA following sevoflurane anesthesia varies from 10% to 66% and is more common in pre-school children. EA is generally short lived without obvious aftereffect. However, it still accompanies with risk of self-injury, and requires extra nursing care, which may delay the discharge and increase the cost of medical care Emergence agitation is diagnosed by a final composite score of greater than or equal to 10 on the Pediatric Anesthesia Emergence Delirium Scale (PAED).(

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 5
Healthy Volunteers: f
View:

• ASA physical status II

• ages from 2-5 years.

• weight more than 6 kg.

• scheduled for cardiac catheterization procedure not exceeding 3 hours.

Locations
Other Locations
Egypt
Amany Hassan Saleh
RECRUITING
Giza
Contact Information
Primary
Amany H Saleh, MD
dr_amanyhassan@hotmail.com
01224259808
Backup
Passaint H Fahim, MD
passaintf@yahoo.com
01000990952
Time Frame
Start Date: 2023-09-20
Estimated Completion Date: 2024-05-01
Participants
Target number of participants: 100
Treatments
Active_comparator: Dexmedetomidine group
25 patients will receive Dexmedetomidine 1 μg/kg bolus over 10 min followed by 0.5 μg/kg/h as maintenance volume-matched 0.9% saline.
Active_comparator: Magnesium group
25 patients will receive IV magnesium as a loading dose 15 mg/kg diluted in 0.9% NaCl given over 10 min followed by 10mg/kg/h IV infusion( for Concentration of solution will not exceed 1gm/25 mL (40 mg/ml).
Active_comparator: Ketamine group
25 patients will receive intravenous (IV) ketamine 1mg/kg diluted in 0.9% NaCl as a loading dose over 10min then 1mg/kg/h IV infusion
Placebo_comparator: Control group
in 25 patients saline will be given as bolus over 10 min then will be infused as maintenance by the same rate of the other groups.
Related Therapeutic Areas
Sponsors
Leads: Cairo University

This content was sourced from clinicaltrials.gov