Propofol Versus Dexmedetomidine Effect on Prevention Emergence Agitation

Emergence Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06312618
• Other study ID #: FMASU MD292/2023
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 15, 2024
• Est. completion date: October 15, 2024

Study information

• Verified date: February 2024
• Source: Ain Shams University
• Contact: Nada Mousa Helal, MSc
• Phone: 1091513200
• Email: nada.mousa[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation

Intervention

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) .
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Vital signs change.	Heart Rate (HR)	at extubation , upon arrival to the PACU and after 15 minute , then after 30 minute in the PACU.
Secondary	Vital signs change.	Mean arterial pressure	at extubation , upon arrival to the PACU and after 15 minute , then after 30 minute in the PACU.
Secondary	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.
Secondary	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.
Secondary	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.