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

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.

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).(

Study Overview

• Status: Recruiting
• Conditions: Anesthesia Emergence Delirium
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Magnesium; Drug: Ketamine; Other: normal saline 0.9% NaCL

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Amany H Saleh, MD; Phone Number: 01224259808; Email: dr_amanyhassan@hotmail.com
• Study Contact Backup: Name: Passaint H Fahim, MD; Phone Number: 01000990952; Email: passaintf@yahoo.com

Study Locations

• Egypt
  • Giza, Egypt, 02
    • Recruiting
    • Amany Hassan Saleh
    • Contact: Amany H Saleh, MD; Phone Number: 1224259808; Email: dr_amanyhassan@hotmail.com
    • Contact: Passaint H Fahim, MD; Phone Number: 01000990952; Email: passaintf@yahool.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Dexmedetomidine; a selective a-2 adrenoceptor agonist, has sedative, analgesic, and anxiolytic effects.
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).	Drug: Magnesium; NMDA (N-methyl-D-aspartate) receptor antagonist
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	Drug: Ketamine; NMDA (N-methyl-D-aspartate) receptor antagonist
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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAED scale 15 min postoperatively	pediatric anesthesia emergence delirium	15 minutes

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Amany Saleh, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): April 15, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Ketamine; Dexmedetomidine
• Other Study ID Numbers: N-122-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No