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CTRI Number  CTRI/2025/03/082724 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 10/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   preventing confusion in kids after anaesthesia: a comparison of two medications  
Scientific Title of Study   Efficacy Dexmedetomidine and Propofol in prevention of Emergence Delirium after using sevoflurane in pediatric patients  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrBhumika Panjwani 
Designation  Junior Resident in departement of anaesthesiology  
Affiliation  Hamidia Hospital , Gandhi Medical College , Bhopal  
Address  operation theatre , 2nd floor , Department of Anaesthesiology , Hamidia hospital , Gandhi Medical College

Bhopal
MADHYA PRADESH
462001
India 
Phone  7693082822  
Fax    
Email  bhumika.anaesthesia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Urmila Keshari  
Designation  Professor in Department of Anesthesiology  
Affiliation  Hamidia Hospital , Gandhi Medical College 
Address  operation theatre , 2nd floor , Department of Anaesthesiology , Hamidia hospital , Gandhi Medical College

Bhopal
MADHYA PRADESH
462001
India 
Phone  9826757745  
Fax    
Email  surmila19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jitendra Kumar  
Designation  Assistant Professor in Department of Anesthesiology  
Affiliation  Hamidia Hospital , Gandhi Medical College  
Address  operation theatre , 2nd floor , Department of Anaesthesiology , Hamidia hospital , Gandhi Medical College

Bhopal
MADHYA PRADESH
462001
India 
Phone  7974710775  
Fax    
Email  jitu.alien@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology , Gandhi Medical College , Bhopal , Madhya Pradesh , 462001 
 
Primary Sponsor  
Name  Gandhi Medical College  
Address  Gandhi Medical College , Bhopal , MP , 262001  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhumika Panjwani   Hamidia Hospital   floor 2 , department of anaesthesiology , block 1 , Gandhi Medical College , Bhopal
Bhopal
MADHYA PRADESH 
7693082822

bhumika.anaesthesia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K00-K95||Diseases of the digestive system, (2) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine , propofol and sevoflurane in surgeries   study of clinical efficacy of dexmedetomidine and propofol in prevention of emergence delirium in sevoflurane induced general anesthesia in pediatric patients  
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  pediatric patients of age group two to eight years , both male and female and ASA grade I and II  
 
ExclusionCriteria 
Details  Parents refusal or not giving Consent
Any illness like mental retardation or developmental delay
known allergy to the study drugs  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of dexmedetomidine and propofol in prevention of sevoflurane induced emergence delirium in pediatric patients   every 10 minutes from study drug administration till 30 minutes of drug administration  
 
Secondary Outcome  
Outcome  TimePoints 
to observe postoperative analgesia , hemodynamic stability and post operative complications if any   every 10 minutes from drug administration till 30 minutes  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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 etc
Dexmedetomidine 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 
 
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