| CTRI Number |
CTRI/2020/05/025409 [Registered on: 28/05/2020] Trial Registered Prospectively |
| Last Modified On: |
12/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Randomized comparison of Magnesium and Dexmedetomodine as adjuvant to Ropivacaine in pediatric caudal block |
|
Scientific Title of Study
|
Comparative evaluation of Magnesium and Dexmedetomidine as adjuvant to Ropivacaine in caudal block in children- A Randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Megha gandotra |
| Designation |
PG anaesthesia |
| Affiliation |
Govt. Medical college jammu |
| Address |
Department of anesthesia
Floor no 2
Govt medical college
Bakshi nagar, jammu
Jammu
JAMMU & KASHMIR
180005
India |
| Phone |
9469163365 |
| Fax |
|
| Email |
megha.gandotra89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naine bhadrala |
| Designation |
Assistant professor Anaesthesia |
| Affiliation |
Govt. Medical college jammu |
| Address |
Department of Anaesthesia
2nd floor
Govt. Medical college
Bakshi nagar,Jammu
Jammu
JAMMU & KASHMIR
180005
India |
| Phone |
9419781087 |
| Fax |
|
| Email |
naine1978@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Megha gandotra |
| Designation |
PG anaesthesia |
| Affiliation |
Govt. Medical college jammu |
| Address |
Department of anesthesia
Floor no 2
Govt medical college
Bakshi nagar, jammu
Jammu
JAMMU & KASHMIR
180005
India |
| Phone |
9469163365 |
| Fax |
|
| Email |
megha.gandotra89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesia floor no 2
Government medical college bakshinagar jammu |
|
|
Primary Sponsor
|
| Name |
Government medical college jammu |
| Address |
Bakshi nagar chowk
Jammu
Jammu and kashmir 180005 |
| 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 Megha Gandotra |
Government medical college jammu |
Department of Anaesthesia
2nd Floor
Govt medical college jammu
Bakshinnagar
Jammu
JAMMU & KASHMIR |
9469163365
megha.gandotra89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Govt medical college Jammu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y998||Other external cause status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caudal block in pediatric age group |
Child is placed in lateral position and sacral hiatus identified. After sterile skin preparation, small sterile 22 guage bevelled needle is advanced at 45 degree angle till a pop is felt by piercing of sacrococcygeal ligament. Needle is flattened and advanced and aspiration for blood and csf performed. If negative, jnjection is given slowly. Child is put jn supjne position for surgery to proceed |
| Comparator Agent |
Dexmedetomodine and magnesium as adjuvant to ropivacaine in caudal block |
Comparator agent in 1st group is Dexmedetomidine 1mcg/kg in 1ml normal saline.
Comparator agent in 2nd group is Magnesium 50 mg in 1 ml normal saline
Control group has 1 ml normal saline as placebo |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA group I or II in age group of 1-10 years, of either sex, , undergoing elective lower abdominal surgeries under general anaesthesia with caudal block supplementation |
|
| ExclusionCriteria |
| Details |
ASA III or more, consent refusal, known allergy to study drugs, any coagulation abnormalities,prolonged surgery (>90min),any intensive need for preop sedation or analgesia, any contraindication to neuraxial blockade (infection,anatomic or neurological abnormality,heart disease,any muscular disorder), use of any medication that affect neurological system |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia and need for rescue analgesia |
At baseline, at end of surgery , 1 hour after surgery 4 hours after surgery up to next 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sedation score and adverse effects if any |
At baseline, at end of surgery , 1 hour after surgery 4 hours after surgery up to next 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
01/06/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
After preanesthetic checkup, the children shall be randomly allocated in 3 groups of 20 patients each receiving 0.2% Ropivacaine 0.75ml/kg caudally with following adjuvants: Group C (control), Group MG (magnesium), Group D (dexmedetomidine) Parameters to be observed are Post op duration of analgesia , sedation score and any adverse effects if any.
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