Clinical trial

Efficacy of Propofol Versus Dexmedetomidine To Prevent Emergence Agitation After Sevoflurane Anesthesia In Children Undergoing Squint Surgery

Name

FMASU MD292/2023

Description

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.

Trial arms

Trial start

2024-03-15

Estimated PCD

2024-09-15

Trial end

2024-10-15

Status

Not yet recruiting

Phase

Early phase I

Treatment

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) .

Arms:

Group 1: Propofol group

Other names:

Diprivan

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).

Arms:

Group 2: Dexmedetomidine group

Other names:

Precedex

Size

Primary endpoint

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).

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-03-15

1 organization

2 products

1 indication

Organization

Product

Indication

Product