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

NCT06077539 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-10-11

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine

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

DRUG

Ketamine

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

DRUG

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Amany Saleh, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2024-04-15
Completion
2024-05-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06077539 on ClinicalTrials.gov