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NCT Number: NCT06977425

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

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

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Key information

Conditions

Magnesium Sulphate Confusion Delirium Dexmedetomidine Emergence Agitation Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Patients Postoperative Complications Signs and Symptoms

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university

Cairo, 11591, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnesium sulphate

Drug

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.

Dexmedetomidine

Drug

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.

Primary outcomes

  1. Pediatric Anesthesia Emergence Delirium Scale

    Time frame: 30 minutes postoperatively

    Pediatric Anesthesia Emergence Delirium Scale (PAED). The PAED Scale consists of five characteristics that are each scored by using a 5-point Likert scale:

    • The child makes eye contact with the caregiver
    • The child is aware of his or her surroundings
    • The child's actions are purposeful,
    • The child is restless
    • The child is inconsolable We set the threshold score for the presence of pediatric emergence delirium using the PAED Scale at a score higher than or equal to 10 based on the sensitivity and specificity reported in the literature.

Secondary outcomes

  1. Richmond agitation sedation scale (RASS)

    Time frame: 30 minutes postoperatively

    The Richmond agitation sedation scale (RASS) assesses five levels of sedation:

    • (5) unarousable with no response to voice or physical stimulation
    • (4) deep sedation with no response to voice but movement to physical stimuli
    • (3) moderate sedation with movement to voice but no eye contact
    • (2) light sedation and briefly awakens (ie, less than 10 seconds) with eye contact to voice
    • (1) drowsy (ie, not fully alert) but has sustained (ie, more than 10 seconds) awakening with eye contact to voice

  2. Heart rate

    Time frame: 30 minutes postoperatively

    Heart rate will be recorded from the start of injection till 30 minutes postoperatively.

  3. Blood pressure

    Time frame: 30 minutes postoperatively

    Blood pressure will be recorded from the start of injection till 30 minutes postoperatively.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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