| CTRI Number |
CTRI/2018/05/014305 [Registered on: 31/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
BEST DOSE AMONG THE THREE |
|
Scientific Title of Study
|
COMPARATIVE EFFICACY OF THREE DIFFERENT DOSES OF INTRANASAL DEXMEDETOMEDINE FOR PREMEDICATION IN CHILDREN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT APPLICABLE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEELAM PRASAD |
| Designation |
PROFESSOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
MAULANA AZAD MEDICAL COLLEGE,BAHADUR SHAH ZAFAR MARG,DELHI
LOK NAYAK JAI PRAKASH
HOSPITAL
Central
DELHI
110002
India |
| Phone |
9968604372 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NEELAM PRASAD |
| Designation |
PROFESSOR |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
MAULANA AZAD MEDICAL COLLEGE,BAHADUR SHAH ZAFAR MARG,DELHI
LOK NAYAK JAI PRAKASH
HOSPITAL
Central
DELHI
110002
India |
| Phone |
9968604372 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
KULDEEP SINGH |
| Designation |
PG STUDENT |
| Affiliation |
MAULANA AZAD MEDICAL COLLEGE |
| Address |
MAULANA AZAD MEDICAL COLLEGE,BAHADUR SHAH ZAFAR MARG,DELHI
LOK NAYAK JAI PRAKASH
HOSPITAL
New Delhi
DELHI
110002
India |
| Phone |
08860237298 |
| Fax |
|
| Email |
kuldeepsingh.831@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTIONAL -MAULANA AZAD MEDICAL COLLEGE,BAHADAUR SHAH ZAFAR MARG,NEW DELHI-110002 |
|
|
Primary Sponsor
|
| Name |
INSTITUTIONAL |
| Address |
MAULANA AZAD MEDICAL COLLEGE |
| 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 |
| NEELAM PRASAD |
MAULANA AZAD MEDICAL COLLEGE |
MAMC,BAHADUR SHAH ZAFAR MARG,NEW DELHI
New Delhi
DELHI |
9968604372
nprasadgovil@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
CHILDREN OF AGE 1-6 YRS,ASA GRADE ONE AND TWO UNDERGOING GENERAL ANESTHESIA, (1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomedine |
Comparing efficacy of three different doses of intranasal dexmedetomedine-0.5microgram/kg, 1microgm/kg , 1.5microgm/kg in children 1-6 yrs of age for anxiolysis and effect over induction. |
| Comparator Agent |
mYPAS scale and INDUCTION COMPLIANCE CHECKLIST |
ASSESSING THE PRE-OPERATIVE ANXIETY IN CHILDREN AGE 1-6 YRS USING mYPAS ANXIETY SCALE AND INDUCTION SCORE USING THE INDUCTION COMPLIANCE CHECKLIST.ASESSING ANXIETY AT BASELINE-JUST AFTER GIVING THE DRUG,30 MIN,45MIN AND JUST AFTER ARRIVAL IN OPERATION THEATRE, WHILE INDUCTION COMPLIANCE AT THE TIME OF ANESTHESIA INDUCTION. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
AGE 1-6 YRS
ASA GRADE ONE AND TWO
PATIENT UNDERGOING GENERAL ANESTHESIA |
|
| ExclusionCriteria |
| Details |
KNOWN ALLERGY OR HYPER SENSITIVITY TO DEXMEDETOMEDINE.
ABERRANT NASAL ANATOMY.
ACUTE OR CHRONIC NASAL TRAUMA THAT MAY PRECLUDE ADEQUATE INTRANASAL DELIVERY OF DRUG.
ANTICIPATED DIFFICULT AIRWAY.
LIVER DYSFUNCTION.
CARDIAC ARRHYTHMIAS, CONGENITAL HEART DISEASE ,MENTL RETARDATION. |
|
|
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 |
| TO EVALUATE AND COMPARE EFFICACY OF THREE DIFFERENT DOSES OF INTRANASAL(ROUTE) DEXMEDETOMEDINE FOR PREMEDICATION IN CHILDREN FOR PREOPERATIVE ANXIETY USING THE mYPAS SCALE TAKING ONE BASELINE THEN AFTER ,30MIN,45MIN,JUST AFTER TAKING IN OPERATION THEATRE |
TO EVALUATE AND COMPARE EFFICACY OF THREE DIFFERENT DOSES OF INTRANASAL DEXMEDETOMEDINE FOR PREMEDICATION IN CHILDREN FOR PREOPERATIVE ANXIETY USING THE mYPAS SCALEEFFICACY OF THREE DIFFERENT DOSES OF INTRANASAL(ROUTE) DEXMEDETOMEDINE FOR PREMEDICATION IN CHILDREN FOR PREOPERATIVE ANXIETY USING THE mYPAS SCALE TAKING ONE AT BASELINE THEN AFTER ,30MIN,45MIN,JUST AFTER TAKING IN OPERATION THEATRE |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-INDUCTION COMPLIANCE USING INDUCTION COMPLIANCE CHECKLIST.
2-HEMODYNAMIC RESPONSES TO DEFINITIVE AIRWAY INSERTION |
HEART RATE,SYSTOLIC BLOOD PRESSURE,DIASTOLIC BLOOD PRESSURE,MEAN ARTERIAL BLOOD PRESSURE WILL BE RECORDED AT IMMEDIATELY BEFORE AND 1,3,5,7,10MINS TO DEFINITIVE AIRWAY INSERTION. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Preoperative anxiety in children is a major concern to the pediatric anesthesiologist. Children may become overtly uncooperative at the time of seperation from parents , venipuncture, or mask application. Preinduction techniques ,aimed at reducing preoperative anxiety. For sedative medications ketamine ,midazolam, fentanyl have been used with variable results. Dexmedetomedine is a highly selective alpha-2 adrenoceptor agonist that provides sedation, anxiolysis and analgesic effects without causing respiratory depression. In children it is a difficult and even traumatic to obtain iv acess and lack of cooperation like swallowing for oral route makes the transmucosal route a more preferred one. We plan to undertake this to objectively assess and compare the efficacy of these three doses of dexmedetomedine as premedications by these objective validated scoring system. |