Comparing the Efficacy of Propofol and Dexmedetomidine in Prevention of Emergence Agitation After Sevoflurane Anesthesia in Children

NCT07799311 | Recruiting Phase 4 DMC

• 1 other identifier: F/522024(ERRC)PIMS
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical study for comparing the efficacy of two drugs i.e propofol and dexmedetomidine in prevention of a group of post operative abnormal behaviours that can occur after sevoflurane anesthesia in children and we will measure this by a special scale which is used to evaluate these behavioural changes.

Conditions

Emergence Delirium, Anesthesia

Outcome Measures

Primary Outcomes (1)

• Emergence Delirium PAED score

  PAED score will be calculated upon arrival in Post Anesthesia care unit then at 5,10,15,30 minutes interval

Study Arms (2)

Group propofol

ACTIVE COMPARATOR

Drug: propofol 1mg/kg

group dexmedetomidine

ACTIVE COMPARATOR

Drug: Dexmedetomidine

Interventions

propofol 1mg/kg DRUG

1mg/kg propofol given 10 minutes before the end of surgery

Group propofol

Dexmedetomidine DRUG

0.3mcg/kg of dexmedetomidine to group D patients will be given after dilution with 10ml of 0.9%saline over 1 min given 10 minutes before extubation

group dexmedetomidine

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age 2-12 years 2-elective inguinal hernia repair under general anesthesia

You may not qualify if:

• congenital anomalies
• allergic to study medications
• chronic pain syndromes
• malnourishment -

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead

Study Sites (1)

Pakistan Institute of Medical Sciences

Islamabad, Federal, 44000, Pakistan

RECRUITING

Related Publications (1)

• Ghada F. Amer & Maha Younis Abdallah (2022) Dexmedetomidine versus propofol for prevention of emergence delirium in pediatric cataract surgery: Double blinded randomized study, Egyptian Journal of Anaesthesia, 38:1, 300-304, DOI: 10.1080/11101849.2022.2077049

  BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Naheed Fatima

  Head of Department

  STUDY CHAIR

Central Study Contacts

Muhammad Haroon Principal Investigator, MBBS, FCPS

CONTACT

+92-333-5236956; haroonanwar22@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: August 28, 2026
• Primary Completion (Estimated): November 28, 2026
• Study Completion (Estimated): November 28, 2026
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)