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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-20

Study Completion Date

2024-05-01

Brief Summary

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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).(

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Detailed Description

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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.

Conditions

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Anesthesia Emergence Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

(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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

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).

Group Type ACTIVE_COMPARATOR

Magnesium

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Ketamine

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

normal saline 0.9% NaCL

Intervention Type OTHER

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

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Ketamine

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

Intervention Type DRUG

Magnesium

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

Intervention Type DRUG

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

Intervention Type OTHER

Eligibility Criteria

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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 .

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No