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

NCT06077539 | Unknown Phase 1

• 1 other identifier: N-122-2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).(

Conditions

Anesthesia Emergence Delirium

Outcome Measures

Primary Outcomes (1)

• PAED scale 15 min postoperatively

  pediatric anesthesia emergence delirium

  15 minutes

Study Arms (4)

Dexmedetomidine group

ACTIVE COMPARATOR

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

Magnesium group

ACTIVE COMPARATOR

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

Ketamine group

ACTIVE COMPARATOR

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

Control group

PLACEBO COMPARATOR

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

Interventions

Dexmedetomidine DRUG

a selective a-2 adrenoceptor agonist, has sedative, analgesic, and anxiolytic effects.

Dexmedetomidine group

Ketamine DRUG

NMDA (N-methyl-D-aspartate) receptor antagonist

Ketamine group

Magnesium DRUG

NMDA (N-methyl-D-aspartate) receptor antagonist

Magnesium group

normal saline 0.9% NaCL OTHER

saline will be given as bolus over 10 min then will be infused as maintenance by the same rate of the other groups

Control group

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Amany Hassan Saleh

Giza, 02, Egypt

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine; Ketamine; Magnesium; Saline Solution

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Amany Saleh, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amany H Saleh, MD

CONTACT

01224259808; dr_amanyhassan@hotmail.com

Passaint H Fahim, MD

CONTACT

01000990952; passaintf@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist not involved in the study will open envelopes and will prepare the drug. All syringes will be prepared by the same investigator not one of the study researchers. Administration of anesthesia and study drugs will be made by other investigators blinded to the study drugs and not involved in the study. Data collection will be done by investigator who is included in the study.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anesthesia ,surgical intensive care and pain management

Model Details: (100) patients will be randomized into four equal groups using computer-generated block randomization and there will be five blocks each block contains 5 patients in each group.

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: September 20, 2023
• Primary Completion: April 15, 2024
• Study Completion: May 1, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)