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Clinical Trials/CTRI/2024/07/070673
CTRI/2024/07/070673
Not yet recruiting
Not Applicable

Effect of recorded mothers voice on postoperative emergence delirium in paediatric patients

ESIC Medical College and Hospital Faridabad1 site in 1 country90 target enrollmentStarted: July 25, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
ESIC Medical College and Hospital Faridabad
Enrollment
90
Locations
1
Primary Endpoint
Incidence of emergence delirium

Overview

Brief Summary

Emergence delirium is an acute confusion state in patients emerging from general anaesthesia.T he incidence of emergence delirium in paediatric patients after general anaesthesia is reported to be ranging from 10% to 80%. It is characterised by being in a dissociated condition of consciousness in which child is irritable, uncoperative, uncompromising and inconsolably crying, moaning, kicking or thrashing. Not many indian studies are available on this topic.

Study Design

Study Type
Interventional
Allocation
Other
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
2.00 Year(s) to 8.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Children aged 2-8years of ASA physical status I or II posted for surgery under general anaesthesia will be included in study.

Exclusion Criteria

  • children with neurological disorders.
  • children with development delays.
  • children with hearing impairments.

Outcomes

Primary Outcomes

Incidence of emergence delirium

Time Frame: Every 10 minutes till 30 minutes

Secondary Outcomes

  • To assess the effect of recorded mothers voice on preoperative anxiety in children before induction of general anaesthesia.(Acceptance of the anaesthesia face mask by the child during inhalational induction.)

Investigators

Sponsor
ESIC Medical College and Hospital Faridabad
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Sarath Mohan T

ESIC Medical College and Hospital Faridabad

Study Sites (1)

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