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NCT Number: NCT07799311

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

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.

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Key information

Conditions

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

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pakistan Institute of Medical Sciences

Islamabad, Federal, 44000, Pakistan

Location status: Recruiting

Location contact

Naheed Fatima, MBBS,FCPS

CONTACT

[email protected]

03005236655

About this study

A randomized clinical trial in which we will compare a single dose propofol with a single dose of dexmedetomodine given at the end of surgery after sevoflurane _based anesthesia to prevent post operative emergence agitation which is a group of behaviours consisting of confusion , disorientation,hyperactivity and even physical harm to themselves and others. this behavioural response is assessed by a score which is called peadriatric anesthesia emergence delerium scale (PEAD) which consist of 5-itms and 5-point scale ,ranging from not at all to extremely.the total score range from 0 to 20,with higher scores indicating more svere emergence agitation . In this study , the PEAD score will be recorded at 0,5,10,15,and 30 minutes after the child reach the recovery room ,and score greater than 10 at any of these readings will be taken as emergence agitation or delerium.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

-

Exclusion criteria

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

Treatment and study plan

propofol 1mg/kg

Drug

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

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

Primary outcomes

  1. Emergence Delirium PAED score

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

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Haroon Principal Investigator, MBBS, FCPS

CONTACT

[email protected]

+92-333-5236956

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Registry information

Official study title

Comparison of Propofol and Dexmedetomidine in Prevention of Emergence Agitation After Sevoflurane Anesthesia Following Inguinal Hernia Repair: A Randomized Control Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2026
Registry last updated
Sep 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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