Efficacy of Intraoperative Magnesium Sulphate vs Dexmedetomidine on Emergence Agitation in Pediatric Patients

Ain Shams University

Status: Completed

Conditions: Emergence Agitation; Dexmedetomidine; Magnesium Sulphate; Pediatric Patients

Treatments: Drug: Magnesium sulphate; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06977425

FMASU MS112/2024

Details and patient eligibility

About

This study aimed to compare the effectiveness of intraoperative magnesium sulfate versus dexmedetomidine infusions on emergence agitation that follows anesthesia using sevoflurane immediately and after 30 min in the post-anesthesia care unit (PACU), regarding Pediatric Anesthesia Emergence Delirium Scale (PAED), Richmond agitation sedation scale (RASS), and hemodynamics

Full description

Emergence agitation (EA) is a postoperative phenomenon that occurs in children after sevoflurane anesthesia, with an occurrence rate of up to 80%.

Dexmedetomidine acts on α-2 adrenergic receptors, producing sedation and hypnosis with anxiolytic effects, without a clinically significant depressive impact on heart rate, blood pressure, and respiratory rate, complementing an earlier study suggesting the possible effective and safe use of dexmedetomidine as a part of anesthesia care to prevent emergence agitation in children.

Magnesium sulfate also has been reported to decrease the incidence and severity of Emergence agitation and the need for postoperative rescue doses of analgesia in children, and its use was not associated with increased postoperative side effects or delayed recovery.

Enrollment: 60 patients

Sex: All

Ages: 4 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 4 to 8 years old.
• Both sexes.
• Patients American Society of Anesthesiologists (ASA) Physical Status I to II.
• Duration of surgery: not exceeding two hours

Exclusion criteria

• Legal guardian refusal.
• Neurological abnormalities, such as cerebral palsy.
• Any physical and/or developmental challenge.
• Patients on sedatives, anticonvulsants, or any medications that may alter conscious level in children.
• Coexisting renal or cardiovascular diseases.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Magnesium sulphate group

Experimental group

Description:

Patients received an initial intravenous loading dose of 30 mg/kg of 10% magnesium sulfate solution over 10 min. This will be followed by a continuous infusion of (10mg/kg/hr) for the entire duration of surgery.

Treatment:

Drug: Magnesium sulphate

Dexmedetomidine group

Experimental group

Description:

Patients received dexmedetomidine infusion 0.5 μg/kg over 10 min as a bolus dose, followed by 0.2 μg/kg/h all over the operation.

Treatment:

Drug: Dexmedetomidine