| CTRI Number |
CTRI/2017/08/009516 [Registered on: 28/08/2017] Trial Registered Prospectively |
| Last Modified On: |
07/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study Between Two Muscle Relaxant drug with respect to onset time,duration of action and side effects,when used in Paediatric Surgeries. |
|
Scientific Title of Study
|
A Comparative Study Between Cisatracurium And Atracurium For Neuromuscular Blockade In Paediatric Surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gunjan |
| Designation |
Senior Resident |
| Affiliation |
IGIMS |
| Address |
Department of Anaesthesiology
IGIMS
Sheikhpur
Patna
Patna
BIHAR
800014
India |
| Phone |
8252259153 |
| Fax |
|
| Email |
gunjansmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Kumar |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of anaesthesiology
IGIMS
Patna
Patna
BIHAR
800014
India |
| Phone |
9534870908 |
| Fax |
|
| Email |
arvind007kumar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr arvind kumar |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of anaesthesiology
IGIMS
Patna
Patna
BIHAR
800014
India |
| Phone |
9534870908 |
| Fax |
|
| Email |
arvind007kumar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,IGIMS, Sheikhpura,Patna, Bihar, 800014 |
|
|
Primary Sponsor
|
| Name |
IGIMS |
| Address |
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 |
| DrGunjan |
Indira Gandhi Institute Of Medical Sciences |
Department of Anaesthediology,
IGIMS
Sheikhpura
Patna
BIHAR |
08252259153
gunjansmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,IGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient specific operative condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cisatracurium, atracurium |
Comparasion of two muscle relaxants in the paediatric age group with respect to onset time and duration of action.also any signs of allergy caused by the drugs will be assessed. |
| Intervention |
Neuromuscular blockade |
Neuromuscular blockade is to be assessed on basis of onset time and duration of action using peripheral nerve Stimulator |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
Qualifies age group,posted for paediatric surgery |
|
| ExclusionCriteria |
| Details |
Patient refusal,allergy to known drugs,neuromuscular disorders,myopathies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the estimated lag time,onset time,duration of action in seconds between two drugs. |
Time taken in seconds from the point of drug administration till the onset of neuromuscular
blockade as shown in the peripheral nerve monitor. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see signs of histamine release following drug administration |
For 10 minutes |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2017 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized double blinded study, to compare the neuromuscular blockade produced by two drugs,atracurium and cisatracurium, in the patients posted for paediatric surgeries between the age group newborn to six months.The parameters to be compared are onset time, lag time and the duration of action of both the drugs.Also any signs of histamine release will be looked for 10 mins following the drug administration. |