Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation

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

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.

Study Overview

• Status: Completed
• Conditions: Emergence Agitation
• Intervention / Treatment: Drug: Propofol; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11517
      • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Propofol group; children will be randomized to receive propofol 1mg/kg over 10 minutes	Drug: Propofol; 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
Active Comparator: Group 2: Dexmedetomidine group; children will be randomized to receive dexmedetomidine 0.2 mcg/kg over 10 minutes	Drug: Dexmedetomidine; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the overall incidence of postoperative Emergence Agitation	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.	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate changes	heart rate (HR) will be measured at extubation , upon arrival to the PACU and after 15 minutes , then after 30 minutes in the PACU.	30 minutes in the PACU
mean arterial pressure (MAP) changes	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.	30 minutes in the PACU
peripheral oxygen saturation (SpO2) changes	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.	30 minutes in the PACU
Proportion of patients with adverse events in the 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.	assessed up to 30 minutes after arrival of patient to PACU.
Proportion of patients with Post Operative Nausea and Vomiting (PONV)	evaluated by a 4-point PONV Scale .	assessed up to 30 minutes after arrival of patient to PACU.
Time to discharge from the PACU.	the time the patients needs to be stable and discharge from the PACU	60 minutes

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Actual): March 15, 2025
• Study Completion (Actual): March 15, 2025

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Imidazoles; Phenols; Benzene Derivatives; Dexmedetomidine; Propofol
• Other Study ID Numbers: FMASU MD292/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No