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

Anesthesia Emergence Delirium Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077539
• Other study ID #: N-122-2023
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 20, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2023
• Source: Cairo University
• Contact: Amany H Saleh, MD
• Phone: 01224259808
• Email: dr_amanyhassan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).(

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Anesthesia Emergence Delirium
• Emergence Delirium

Intervention

Drug:
• Dexmedetomidine
a selective a-2 adrenoceptor agonist, has sedative, analgesic, and anxiolytic effects.
• Ketamine
NMDA (N-methyl-D-aspartate) receptor antagonist
• Magnesium
NMDA (N-methyl-D-aspartate) receptor antagonist

Other:
• normal saline 0.9% NaCL
saline will be given as bolus over 10 min then will be infused as maintenance by the same rate of the other groups

Locations

Country	Name	City	State
Egypt	Amany Hassan Saleh	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PAED scale 15 min postoperatively	pediatric anesthesia emergence delirium	15 minutes