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To compare the effects of intravenously given Propofol or Dexmedetomidine in reducing the incidence of Emergence Agitation (a frequent postoperative behavioural disturbance) with Sevoflurane (a commonly used anaesthetic agent for paediatrics)

EFFECT OF INTRAVENOUS PROPOFOL AND DEXMEDETOMIDINE ON EMERGENCE AGITATION IN CHILDREN UNDER SEVOFLURANE ANAESTHESIA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012698
Enrollment
120
Registered
2018-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Children aged 1-8 years ASA physical status I and II coming for infraumbilical surgery

Interventions

Intervention1: DEXMEDETOMIDINE: Intravenous single dose Propofol and Dexmedetomidine in reducing the incidence of Emergence Agitation in children under Sevoflurane anaesthesia Control Intervention1: P

Sponsors

PRINCY MOL BIJU
Lead Sponsor
DR SAM PHILIP
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients of ASA physical status I & II aged between 1-8 years scheduled for elective infraumbilical surgery

Exclusion criteria

Exclusion criteria: 1)Known allergy to study medications 2)Developmental delay, pre existing neurological dysfunction and agitation (eg Downs syndrome, Autism), mental retardation, attention deficit hyperactivity disorders 3)Regular use of medications like sedatives or anticonvulsants 4)Psychological/ emotional disorder, cognitive problems 5)Any contraindication to caudal block 6)Children who have impairment of vision or hearing- that would probably result in post operative disorientation

Design outcomes

Primary

MeasureTime frame
To compare the effectiveness of Intravenous Propofol and Dexmedetomidine in reducing the incidence of emergence agitation in children under Sevoflurane anaesthesia by using Craveros Emergence Agitation ScaleTimepoint: at 5,10,15 and 30 mninutes after discontinuation of Sevoflurane—

Secondary

MeasureTime frame
a)To compare the emergence time between the groups receiving Propofol and Dexmedetomidine b)To compare the duration of Post Anaesthesia Care Unit stay between the two groups Timepoint: time from discontinuation of Sevoflurane to time of discharge from the PACU—

Countries

India

Contacts

Public ContactPrincy Mol Biju

MOSC Medical College, Kolenchery

drsam_p@hotmail.com9496917505

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026