Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Emergence Agitation

Treatments: Drug: Propofol; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06312618

FMASU MD292/2023

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Group 1: Propofol group

Active Comparator group

Description:

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

Treatment:

Drug: Propofol

Group 2: Dexmedetomidine group

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine