| CTRI Number |
CTRI/2024/03/064397 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Other (Specify) [DosageDexmed0.5mcg/kgto2mcg/kg] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Dexmedetomidine dose required in children undergoing laparoscopic surgeries for post op pain relief |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF DEXMEDETOMIDINE DOSES
(0.5MCG/KG VS 1MCG/KG) AS AN ADJUVANT TO 0.25%
BUPIVACAINE FOR ULTRASOUND-GUIDED TRANSVERSUS
ABDOMINIS PLANE (TAP) BLOCK IN CHILDREN UNDERGOING LAPAROSCOPIC SURGERIES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARANYA V |
| Designation |
PG Student |
| Affiliation |
Army Hospital R and R |
| Address |
2nd floor, Dept of Anaesthesiology and Critical Care
Dept Of Anaesthesiology and Critical care
New Delhi
DELHI
110057
India |
| Phone |
9962989912 |
| Fax |
|
| Email |
saranyavenumbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brig Rajeev Nair |
| Designation |
MBBS, MD, DM Cardiac anaesthetist |
| Affiliation |
Army Hospital R and R |
| Address |
Army Hospital R and R
Dept of Anaesthesiology and Critical care
Dept of Anaesthesiology and Critical care
New Delhi
DELHI
110057
India |
| Phone |
7757024594 |
| Fax |
|
| Email |
rjv.nr1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SARANYA V |
| Designation |
PG Student |
| Affiliation |
Army Hospital R and R |
| Address |
2nd floor, Dept of Anaesthesiology and Critical care
Dept of Anaesthesiology and Critical care
New Delhi
DELHI
110057
India |
| Phone |
9962989912 |
| Fax |
|
| Email |
saranyavenumbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| 2nd floor, Dept of Anaesthesiology and Critical care, Army Hospital R and R, Delhi Cannt |
|
|
Primary Sponsor
|
| Name |
Army hospital R and R |
| Address |
Army hospital R and R
Department of Anaesthesiology and Critical care
New Delhi 110057 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Saranya |
Army Hospital R and R |
2nd Floor, Dept of Anaesthesiology and Critical care, Army Hospital R and R, Delhi Cant
New Delhi
DELHI |
01123338196
saranyavenumbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Army Hospital Delhi Cannt |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
Comparison of Dexmedetomidine doses 0.5mcg/kg and 1mcg/kg in Transversus Abdominis Plane (TAP) Block in children undergoing laparoscopic surgeries for post op analgesia |
| Intervention |
Transverse Abdominis Plane Block (TAP) Block |
Details Add New
1 INTERVENTION Transverse Abdominis Plane Block (TAP) Block in children undergoing laparoscopic surgeries for post op pain Comparison of Dexmedetomidine doses 0.5mcg/kg and 1mcg/kg in Transversus Abdominis Plane (TAP) Block in children undergoing laparoscopic surgeries for post op analgesia |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric patients aged 2 to 10 years.
(b) Scheduled for laparoscopic surgeries.
(c) Patients with written informed consent of parents
|
|
| ExclusionCriteria |
| Details |
(a) Parental refusal to undergo the procedure.
(b) Known allergy to the local anesthetic drug used in the procedure.
(c) History of cardio vascular, respiratory disease and Hepatorenal
insufficiency.
(d) Presence of coagulopathies.
(e) Patients taking Adrenoceptor agonist/ antagonist
(f) Inability to comply with study requirements |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the difference of mean time to first rescue analgesia with 0.5mcg/kg and 1mcg/kg Dexmedetomidine in USG guided TAP Block for paediatric patients undergoing laparoscopic surgeries using CHEOPS pain scale |
First 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The total number of analgesic doses given in 24hrs after TAP Block in post op period |
Upto 24hrs in post op period |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="46"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
29/03/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Email has been accepted |