| 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
|
|
|
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
|
|
|
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 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 |