Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation

NCT ID: NCT06312618

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2025-03-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Propofol group

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

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: 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) .

Group 2: Dexmedetomidine group

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: 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).

Interventions

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) .

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

Diprivan; Precedex

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ain Shams University

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

FMASU MD292/2023

Identifier Type: -

Identifier Source: org_study_id