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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06077539
Other study ID # N-122-2023
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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 .

Study Design


Related Conditions & MeSH terms


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
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