| CTRI Number |
CTRI/2024/09/074208 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of 2 different doses of Dexmedetomidine to prevent adverse respiratory events in Paediatric population. |
|
Scientific Title of Study
|
Comparison of two different dosages of premedication with dexmedetomidine to prevent adverse respiratory events after removal of supraglottic airway devices in paediatric patients.A prospective randomized study |
| 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 ANKITA ASHISH |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences |
| Address |
Dept Of Anesthesia,Neuro OT Complex ,1ST Floor Ward Block,IGIMS,Sheikhpura,Patna,Bihar 800014
Patna
BIHAR
800014
India |
| Phone |
7004224089 |
| Fax |
|
| Email |
ankitaashish257@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MUMTAZ HUSSAIN |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences |
| Address |
DEPT OF ANESTHESIA,NEURO OT COMPLEX ,1ST FLOOR WARD BLOCK,IGIMS,SHEIKPURA,PATNA,BIHAR 800014
Patna
BIHAR
800014
India |
| Phone |
7004224089 |
| Fax |
|
| Email |
drhussain72@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ANKITA ASHISH |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Indira Gandhi Institute Of Medical Sciences |
| Address |
DEPT OF ANESTHESIA,NEURO OT COMPLEX ,1ST FLOOR WARD BLOCK,IGIMS,SHEIKPURA,PATNA,BIHAR 800014
Patna
BIHAR
800014
India |
| Phone |
7004224089 |
| Fax |
|
| Email |
ankitaashish257@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute Of Medical Sciences,Dept of Anesthesia Neuro OT complex, First floor ward block,IGIMS,Sheikpura,Patna. |
|
|
Primary Sponsor
|
| Name |
DR ANKITA ASHISH |
| Address |
DEPT OF Anesthesia,Neuro OT Complex,1st Floor Ward Block ,IGIMS,Sheikhpura,Patna. |
| 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 Ankita Ashish |
Indira Gandhi Institute of Medical Sciences,Patna |
Dept of Anaesthesia,Neuro OT Complex, 1ST Floor Ward Block,IGIMS Sheikhpura,Patna,Bihar.
Patna
BIHAR |
7004224089
ankitaashish257@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES PATNA |
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 |
| Intervention |
Comparison Of Two Different Dosages Of Dexmedetomidine In Paediatric age group. |
The Two Different dosages Of Dexmedetomidine is used to prevent adverse respiratory events after removal of supraglottic airway devices in paediatric age group in period of 18 months |
| Comparator Agent |
Two different doses of Dexmedetomidine |
Here two different doses of dexmedetomidine in 1 group(0.5microgram/kg)and in another group(1microgram/kg) is used in period of 18 months
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.Parenteral consent.
2.Patients of ASA grade 1&2.
3.Patients scheduled for surgeries of less than 2 hours |
|
| ExclusionCriteria |
| Details |
1.History of congenital heart disease,neurological disease and asthma.
2.Patients with hiatal hernia,major abdominal or thoracic surgery.
3.Patients with full stomach.
4.Difficult airway or facial anomaly. |
|
|
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 see occurence of any one of respiratory events like coughing,bronchospasm,LMA biting. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see emergence agitation, postoperative nausea & vomiting. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
25/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2024 |
| 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
|
To study the Effects of two different doses of dexmedetomidine in paediatric age group and see the primary adverse respiratory events like coughing,LMA biting, bronchospasm,airway obstruction, and study secondary outcome like emergence agitation,post operative nausea and vomiting, after removal of supraglottic airway devices. |