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

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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07799311
Enrollment
114
Registered
2026-09-02
Start date
2026-08-28
Completion date
2026-11-28
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergence Delirium, Anesthesia

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.

Detailed description

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.

Interventions

DRUGpropofol 1mg/kg

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

DRUGDexmedetomidine

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

Sponsors

Pakistan Institute of Medical Sciences
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

1. congenital anomalies 2. allergic to study medications 3. chronic pain syndromes 4. malnourishment -

Design outcomes

Primary

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

Countries

Pakistan

Contacts

CONTACTMuhammad Haroon Principal Investigator, MBBS, FCPS
haroonanwar22@gmail.com+92-333-5236956
STUDY_CHAIRNaheed Fatima

Head of Department

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026