| CTRI Number |
CTRI/2024/02/063307 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Magnesium Sulphate as Adjuvant in Acute Organophosphorus Poisoning |
|
Scientific Title of Study
|
Magnesium Sulphate As Adjuvant To Standard Therapy In Acute Organophosphorus Compound Poisoning : A Randomized Controlled Trial |
| 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 Naveen Singh |
| Designation |
Resident Doctor |
| Affiliation |
J.L.N. Medical College Ajmer |
| Address |
Department of Emergency Medicine J.L.N. Medical College and Hospital,Ajmer Rajasthan -305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
9587366798 |
| Fax |
|
| Email |
naveenrathore6191@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Jain |
| Designation |
Head of Department |
| Affiliation |
J.L.N. Medical College Ajmer |
| Address |
Department of Emergency Medicine J.L.N. Medical College and Hospital,Ajmer Rajasthan -305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
vinodkanwar6191@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveen Singh |
| Designation |
Resident Doctor |
| Affiliation |
J.L.N. Medical College Ajmer |
| Address |
Department of Emergency Medicine J.L.N. Medical College and Hospital,Ajmer Rajasthan -305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
9587366798 |
| Fax |
|
| Email |
naveenrathore6191@gmail.com |
|
|
Source of Monetary or Material Support
|
| J.L.N. Medical College and Hospital ,Ajmer,Rajasthan,India -305001 |
|
|
Primary Sponsor
|
| Name |
JLN Medical College and Hospital |
| Address |
J.L.N. Medical College and Hospital ,Ajmer,Rajasthan,India -305001 |
| 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 Naveen Singh |
J.L.N. Medical College and Hospital |
Department of Emergency Medicine, J.L.N. Medical College and Hospital, Ajmer ,Rajasthan ,305001
Ajmer
RAJASTHAN |
9587366798
naveenrathore6191@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee J.L.N. Medical College Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T600||Toxic effect of organophosphate and carbamate insecticides, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magnesium sulphate |
dose 4gm mgs04 diluted in 50 ml NS OVer 30 min IV |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients arriving in the emergency OPD with history of OPC consumption and clinical features of cholinergic toxidrome of typical organophosphorus compound poisoning. |
|
| ExclusionCriteria |
| Details |
Doubtful history
Poisoning with unknown compound
Treatment initiated before admission
Patient refusal to consent
Patient sensitive /allergic to any of the study drugs.
Cardiovascular disease patients(1-and2-degree heartblock)
Severe hepatic and renal disease.
History of epilepsy or bleeding tendencies
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of magnesium sulphate as adjuvant to the standard therapy (Atropine and oximes) in reducing morbidity and mortality. |
zero time at time of admission
15 min.
30 min.
45 min.
1 hour
1.5 hour
2 hour
4 hour
6 hour
8 hour
12 hour
16 hour
20 hour
24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the requirement of atropine.
To compare the need for intubation and ventilation and ICU Stay.
To calculate the duration of hospital stay
|
zero time at the time of admission
5 min
10 min
15 min
45 min
1 hour
1.5 hour
2 hour
4 hour
6 hour
8 hour
12 hour
16 hour
20 hour
24 hour |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/03/2024 |
| 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="1"
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
|
In this study, we will study and compare the morbidity and mortality
associated with standard therapy (Atropine and oximes) versus addition of magnesium
sulphate as adjuvant to the standard therapy (Atropine and oximes) in acute
organophosphorus compound poisoning. |