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: Not yet recruiting
• Conditions: Emergence Agitation
• Intervention / Treatment: Drug: Propofol; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nada Mousa Helal, MSc; Phone Number: 0020 1091513200; Email: nada.mousa@med.asu.edu.eg

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	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	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
Vital signs change.	Heart Rate (HR)	at extubation , upon arrival to the PACU and after 15 minute , then after 30 minute in the PACU.
Vital signs change.	Mean arterial pressure	at extubation , upon arrival to the PACU and after 15 minute , then after 30 minute in the PACU.
Vital signs change.	peripheral oxygen saturation (SpO2)	at extubation , upon arrival to the PACU and after 15 minute , then after 30 minute 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 minute 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 minute after arrival of patient to PACU.

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): October 15, 2024

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 (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Delirium; Aberrant Motor Behavior in Dementia; Psychomotor Agitation; Emergence Delirium; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Propofol; Dexmedetomidine
• Other Study ID Numbers: FMASU MD292/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No