Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation

Phase 4

Recruiting

• Conditions: Emergence Agitation
• Interventions: Drug: Propofol; Drug: Dexmedetomidine

• Registration Number: NCT06312618
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-03-08
• Study Start: 2024-03-15
• Study First Posted: 2024-03-15
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-02-15
• Study Completion: 2025-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Propofol group	Propofol	children will be randomized to receive propofol 1mg/kg over 10 minutes
Group 2: Dexmedetomidine group	Dexmedetomidine	children will be randomized to receive dexmedetomidine 0.2 mcg/kg over 10 minutes

Primary Outcome Measures

Name	Time	Method
the overall incidence of postoperative Emergence Agitation	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 Outcome Measures

Name	Time	Method
Proportion of patients with Post Operative Nausea and Vomiting (PONV)	assessed up to 30 minutes after arrival of patient to PACU.	evaluated by a 4-point PONV Scale .
Time to discharge from the PACU.	60 minutes	the time the patients needs to be stable and discharge from the PACU
peripheral oxygen saturation (SpO2) changes	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.
Proportion of patients with adverse events in the PACU	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.
heart rate changes	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.
mean arterial pressure (MAP) changes	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.

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt