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Clinical Trials/CTRI/2025/03/082724
CTRI/2025/03/082724
Not yet recruiting
Not Applicable

Efficacy Dexmedetomidine and Propofol in prevention of Emergence Delirium after using sevoflurane in pediatric patients

Gandhi Medical College1 site in 1 country90 target enrollmentStarted: March 25, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Gandhi Medical College
Enrollment
90
Locations
1
Primary Endpoint
To evaluate the efficacy of dexmedetomidine and propofol in prevention of sevoflurane induced emergence delirium in pediatric patients

Overview

Brief Summary

Emergence Delirium(ED) is considered a major problem during early stages of recovery from general anaesthesia in children . It’s characterised by psychomotor agitation , perceptual disturbances , hallucinations , agitation , confusion. This also includes inconsolable crying , moaning , restlessness , thrashing on bed.Various etiologically factors have been known to cause it like Pre school age , Pre operative anxiety, surgical procedures like otorhinology , ophthalmology procedures etc and also mode of Anaesthesia (inhalational , intravenous) and Postoperative pain. Sevoflurane ia a preferred inhalational agent for pediatric population due to lack of airway irritation , hemodynamic stability , sweet smell, low cardio depressive effect , hepatotoxicity , and rapid recovery from anaesthesia. Emergence Delirium in pediatric patients who underwent surgeries under general anaesthesia using sevoflurane.When pain and other cofounders are controlled, the incidence is around 20-30% , Multiple drugs have been used in previous studies to prevent ED including fentanyl , propofol , Benzodiazapines etcDexmedetomidine due to its alpha agonist activity provides better sedation, analgesia and antiemetic effect with no respiratory depression at clinical dosages . It is potent analgesic , provides anxiolysis and sedation. To be given 0.2 MCG/kg diluted upto 20 ml with NS over 10 minutes.Propofol is non opioid , non barbiturate , sedative , hypnotic agent with rapid onset and short duration of action.It showed an overall protective effect against ED , when given as a bolus at the end of anaesthesia. Dose to be given is 0.1 mg/kg.In this study we hypothesise that dexmedetomidine and propofol both are equally effective in preventing ED caused due to sevoflurane.The aim of this study is to determine whether dexmedetomidine or propofol administered just before termination of sevoflurane decrease the incidence of ED caused due to sevoflurane

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

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

Inclusion Criteria

  • pediatric patients of age group two to eight years , both male and female and ASA grade I and II.

Exclusion Criteria

  • Parents refusal or not giving Consent Any illness like mental retardation or developmental delay known allergy to the study drugs.

Outcomes

Primary Outcomes

To evaluate the efficacy of dexmedetomidine and propofol in prevention of sevoflurane induced emergence delirium in pediatric patients

Time Frame: every 10 minutes from study drug administration till 30 minutes of drug administration

Secondary Outcomes

  • to observe postoperative analgesia , hemodynamic stability and post operative complications if any(every 10 minutes from drug administration till 30 minutes)

Investigators

Sponsor
Gandhi Medical College
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

DrBhumika Panjwani

Hamidia Hospital , Gandhi Medical College , Bhopal

Study Sites (1)

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