| CTRI Number |
CTRI/2025/04/084713 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Two Medicines to Help Children Relax Before Surgery: Dexmedetomidine vs Midazolam
|
|
Scientific Title of Study
|
A Study Comparing Nebulised Dexmedetomidine vs midazolam as premedicant in pediatric patient undergoing elective surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashika Yadav |
| Designation |
Post Graduate Student |
| Affiliation |
Jawaharlal Nehru Medical College and hospital |
| Address |
Department of anaesthesia, Jawaharlal Nehru Medical College and hospital ajmer, rajasthan 305001
India
Ajmer
RAJASTHAN
305001
India |
| Phone |
9468177278 |
| Fax |
|
| Email |
ydvyashika99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Mathur |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College and hospital ajmer rajasthan ,305001 |
| Address |
Department of anaesthesia, Jawaharlal Nehru Medical College and hospital, ajmer, rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414003933 |
| Fax |
|
| Email |
drpoojarawat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Mathur |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College and hospital ajmer rajasthan ,305001 |
| Address |
Department of anaesthesia, Jawaharlal Nehru Medical College and hospital, ajmer, rajasthan
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414003933 |
| Fax |
|
| Email |
drpoojarawat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College and hospital ajmer rajasthan,305001 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College and hospital |
| Address |
Jawaharlal Nehru Medical College and hospital ajmer rajasthan,India , 305001 |
| 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 Yashika Yadav |
JLN Medical College, Ajmer, Rajasthan |
Department of Anesthesia, new ot, first floor, JLN Hospital, Kalakand Bagh, Ajmer, Rajasthan
Ajmer
RAJASTHAN |
9468177278
ydvyashika99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Principal and controller JLNMC AJMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NEBULISED inj DEXMEDETOMIDINE 2MICROGRAM /KG
nebulised inj midazolam 2mg/kg |
with due approval from the institutional ethical comittee, a prospective randomised double blind study is planned on 90 patients aged 3-10 years who will be undergoing elective surgical procedures under general anesthesia, participants will be allocated in group D receiving nebulised dexmedetomidine and group M receiving nebulised midazolam at above mentioned doses will be compared for sedation ,parent separation anxiety, face mask acceptance, emergence reaction , a written and informed consent will be taken from parents of participants. |
| Intervention |
NEBULISED inj DEXMEDETOMIDINE 2MICROGRAM /KG nebulised inj midazolam 2mg/kg |
with due approval from the institutional ethical comittee, a prospective randomised double blind study is planned on patients aged 3-10 years who will undergoing elective surgical procedures under general anesthesia, participants will be allocated in group d receiving nebulised dexmedetomidine and group M receiving nebulised midazolam at above mentioned doses will be compared for sedation ,parent separation anxiety, face mask acceptance, emergence reaction , a written and informed consent will be taken from parents of participants. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1 patients belonging to ASA physical status 1 and 2
2 patients aged 3-10years
3 patients posted for elective surgical procedures under general anesthesia |
|
| ExclusionCriteria |
| Details |
1 parent refusal
2 emergency
3 children with known allergy to study drugs
4 significant organ dysfunction
5 congenital disorders
6 behavioural disorders
7 children with more than 85th percentile of body mass index for age percentiles |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment of sedation score |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| parental separation score |
at 5min, 10min, 20min, 30min |
| mask acceptance score |
at 5min, 10min, 20min, 30min |
| assessment of recovery |
|
| assessment of emergence agitation |
|
|
|
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)
|
30/04/2025 |
| 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="0"
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
|
This will be a double blinded randomised study conducted to evaluate efficacy of nebulised dexmedetomidine 2micogram/kg and nebulised midazolam0.2mg/kg, study drugs will be diluted in 3ml of 0.9% normal saline as premedication in children aged between 3-10 years undergoing surgery under general anesthesia ,administred 30 mins before the induction of general anesthesia via jet nebuliser , in ASA 1 or 2 patients with exemption of all exclusion criteria mentioned above with primary objective of comparing the efficacy of nebulised dexmedetomidine and nebulised midazolam as sedative premedication . Secondary objectives being comparing the premedicants in terms of achieving ,alleviating parent separation anxiety, providing better face mask acceptance, least emergence reactions. Group D receiving nebulised dexmedetomidine and group M receving nebulised midazolam in above mentioned doses. preanesthetic evaluation will be done previous day, informed written consent will be taken prior to surgery , all emergency drugs and equipments will be kept ready in prior. patient will be monitored preoperative, intraoperative and postoperatively. the parameters will be recorded at predescribed intervals and documented . data will be analysed statistically using standard qualitative and quantitative tests , continous variables will be analysed using student paired test and categorical variables will be analysed using chi square test . P value less than 0.05 will be considred significant.
|