Dexmedetomidine Versus Ketamine Versus Magnesium Sulfate for the Prevention of Emergence Agitation Following Sevoflurane Induced Anesthesia in Cardiac Catheterization in Pediatrics

Cairo University (CU)

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Anesthesia Emergence Delirium

Treatments

Other: normal saline 0.9% NaCL

Drug: Dexmedetomidine

Drug: Magnesium

Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT06077539

N-122-2023

Details and patient eligibility

About

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).(

Full description

Sevoflurane induced anesthesia does not cause significant cardiac depression and dysrrhythmias as compared to halothane. Sevoflurane anesthesia is also easy to titrate for maintaining an adequate level of anesthesia, especially for the intubated. It also is a potent bronchodilator, which can offer an added benefit especially in children with a history of asthma. For all above reasons sevoflurane has clearly become the inhalation induction agent of choice.

The exact reasons for a higher incidence of EA with sevoflurane are not well explained. seizure activity in previously nonepileptic patients has been detected with electroencephalography during sevoflurane anesthesia.

One of the proposed treatments for EA is the use of opioids; however, it carries the risk of an extended Post Anesthetic Care Unit (PACU) stay resulting in parents' discomfort and added costs. Therefore, analgesic adjuvants with NMDA (N-methyl-D-aspartate) receptor antagonist functions, such as ketamine and magnesium sulfate have been tried to control this phenomenon in children.

Also, Dexmedetomidine, a selective a-2 adrenoceptor agonist, has sedative, analgesic, and anxiolytic effects. It was proved that α2 agonists decrease emergence agitation by their analgesic effect as well as by minimizing the anesthetic requirements.

In the review of literature this is the first study comparing the effectiveness of the three drugs ketamine, magnesium sulfate and dexmedetomidine infusions together in one study on the incidence of emergence agitation after sevoflurane induced anesthesia in children.

Enrollment

100 estimated patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

ASA physical status II
ages from 2-5 years.
weight more than 6 kg.
scheduled for cardiac catheterization procedure not exceeding 3 hours.

Exclusion criteria

psychological disorder or cognitive delay.
chronic or acute intake of any sedative drug or anticonvulsant drugs.
Any neurological condition that will limit ability to communicate with, or understand a practitioner.
those with coexisting renal diseases , any reported allergy to the given medications.
legal guardian refusal .

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 4 patient groups, including a placebo group

Dexmedetomidine group

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Magnesium group

Active Comparator group

Description:

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).

Treatment:

Drug: Magnesium

Ketamine group

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine

Control group

Placebo Comparator group

Description:

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.