Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation

NCT06312618 | Completed Phase 4

• 1 other identifier: FMASU MD292/2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• heart rate changes

  30 minutes in the PACU

• mean arterial pressure (MAP) changes

  30 minutes in the PACU

• peripheral oxygen saturation (SpO2) changes

  30 minutes in the PACU

• Proportion of patients with adverse events in the PACU

  assessed up to 30 minutes after arrival of patient to PACU.

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

  assessed up to 30 minutes after arrival of patient to PACU.

Study Arms (2)

Group 1: Propofol group

ACTIVE COMPARATOR

children will be randomized to receive propofol 1mg/kg over 10 minutes

Drug: Propofol

Group 2: Dexmedetomidine group

ACTIVE COMPARATOR

children will be randomized to receive dexmedetomidine 0.2 mcg/kg over 10 minutes

Drug: Dexmedetomidine

Interventions

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) .

Also known as: Diprivan

Group 1: Propofol group

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).

Also known as: Precedex

Group 2: Dexmedetomidine group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 11517, Egypt

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 15, 2024
• Study Start: March 15, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)