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OpenTrials
Completed

NCT Number: NCT06312618

Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation

The goal of this clinical trial is to compare Propofol versus Dexmedetomidine in children undergoing squint surgery. The main question it aims to answer is:

• Which drug is more effective in preventing the appearance of Emergence Agitation in children after sevoflurane anesthesia in squint surgery, propofol or dexmedetomidine?

Emergence agitation (EA) is a period of restlessness, agitation, inconsolable crying, disorientation, delusions, and hallucinations with impaired cognition and memory that commonly occurs in children undergoing ophthalmic surgery especially after Short acting volatile agents such as sevoflurane.

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Key information

Conditions

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

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University

Cairo, Cairo Governorate, 11517, Egypt

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pediatric patients from 3 to 7 years.
  • American Society of Anesthesiologists (ASA) Physical Status Class-I and II.
  • Patients undergo squint surgery.

Exclusion criteria

  • Declining to give written informed consent by patient legal guardian.
  • Age younger than 3 years or older than 7 years.
  • ASA classification ≥ III.
  • History of allergy to the medications used in the study or egg products.
  • Psychiatric disorder
  • Other co-morbidities or congenital anomalies or neurological.

Treatment and study plan

Propofol

Drug

After completion of the procedure and after regain muscle power sevoflurane administration will be ceased. children will be randomized to receive propofol

1mg/kg over 10 minutes (group 1) .

Other names: Diprivan

Dexmedetomidine

Drug

After completion of the procedure and after regain muscle power sevoflurane administration will be ceased. children will be randomized to receive dexmedetomidine 0.2 mcg/kg over 10 minutes (group 2).

Other names: Precedex

Primary outcomes

  1. the overall incidence of postoperative Emergence Agitation

    Time frame: EA incidence and severity will be determined using (PAED) scale at extubation (E0), upon arrival to the Post Anesthesia Care Unit (PACU) E1 and after 15 minute (E2), then after 30 minute in the PACU (E3).

    Pediatric Anesthesia Emergence Delirium (PAED) scale will be use to assess the incidence of Emergence Agitation (EA) A PAED score of 10 or higher is considered to be diagnostic of EA, but a score of 12 or higher is more sensitive and specific.

Secondary outcomes

  1. heart rate changes

    Time frame: 30 minutes in the PACU

    heart rate (HR) will be measured at extubation , upon arrival to the PACU and after 15 minutes , then after 30 minutes in the PACU.

  2. mean arterial pressure (MAP) changes

    Time frame: 30 minutes in the PACU

    mean arterial pressure (MAP) will be measured at extubation , upon arrival to the PACU and after 15 minutes , then after 30 minutes in the PACU.

  3. peripheral oxygen saturation (SpO2) changes

    Time frame: 30 minutes in the PACU

    peripheral oxygen saturation (SpO2) will be measured at extubation , upon arrival to the PACU and after 15 minutes , then after 30 minutes in the PACU.

  4. Proportion of patients with adverse events in the PACU

    Time frame: assessed up to 30 minutes after arrival of patient to PACU.

    including oxygen desaturation defined as SpO2 < 90%, regarded as severe desaturation when SpO2 < 85%, bradycardia defined as HR < 80 beats/min , shivering, dizziness, laryngospasm, severe coughing, and reintubation.

  5. Proportion of patients with Post Operative Nausea and Vomiting (PONV)

    Time frame: assessed up to 30 minutes after arrival of patient to PACU.

    evaluated by a 4-point PONV Scale .

  6. Time to discharge from the PACU.

    Time frame: 60 minutes

    the time the patients needs to be stable and discharge from the PACU

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Efficacy of Propofol Versus Dexmedetomidine To Prevent Emergence Agitation After Sevoflurane Anesthesia In Children Undergoing Squint Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 15, 2024
Registry last updated
Oct 2, 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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