| CTRI Number |
CTRI/2022/02/040474 [Registered on: 21/02/2022] Trial Registered Prospectively |
| Last Modified On: |
11/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Can perioperative infusion of magnesium sulfate reduce blood sugar levels in diabetic patients undergoing cardiac surgeries |
|
Scientific Title of Study
|
The Effect of Perioperative Magnesium Sulfate on Blood Sugar in Patients with Diabetes Mellitus Undergoing Cardiac Surgery: A Double-Blinded Randomized Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankur Jain |
| Designation |
post graduate student |
| Affiliation |
Rajasthan Medical Council |
| Address |
Room no. 611, Family hostel no. 7, MDM hopsital, Jodhpur
Govt. Dispensary Campus, Sardar Patel Marg, Near Sahkar Bhawan, jaipur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9780111839 |
| Fax |
|
| Email |
ankurjain2312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Karnawat |
| Designation |
Senior professor |
| Affiliation |
Rajasthan Medical Council |
| Address |
7, Pal Link Road, Kamla Nehru Nagar,Jodhpur
Govt. dispensary Campus, Sardar Patel Marg, Near Sahkar Bhawan, Jaipur
Jaipur
RAJASTHAN
342003
India |
| Phone |
9828033321 |
| Fax |
|
| Email |
dr.rakeshkarnawat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankur Jain |
| Designation |
Post graduate student |
| Affiliation |
Rajasthan Medical Council |
| Address |
Room no. 611, family hostel 7 , MDM hospital jodhpur
Govt. dispensary campus, sardar patel marg, near sahkar bhawan, jaipur
Jaipur
RAJASTHAN
342003
India |
| Phone |
9780111839 |
| Fax |
|
| Email |
ankurjain2312@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr SN medical college jodhpur |
|
|
Primary Sponsor
|
| Name |
DR Sampurnanand Medical College |
| Address |
DR Sampurnanand Medical college,Residency Road, Sector-D, Shastri Nagar, JODHPUR |
| 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 |
| Ankur Jain |
Matura Das Mathur Hospital |
Cardiothoracic Operation Theatre Mathura Das Mathur Hospital, DR Sampurnanand Medical College, Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
9780111839
ankurjain2312@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, DR SAMPURNANAND MEDICAL COLLEGED,JODHPUR |
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 |
Magnesium sulfate |
perioperative magnesium sulfate infusion will be given to patients at dose of 15mg/kg/hr.blood sugar levels, potassium and magnesium will be measured at specified time intervals. |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
all patients with adult age group and both sex with diabetes mellitus irrespective of the previous glycemic index control, but controlled baseline blood sugar levels in the past 24 hours of the surgery, LVEF> 40% presenting for cardiac surgery using CPB under general anaesthesia will be included in the study. |
|
| ExclusionCriteria |
| Details |
patients with congestive heart failure, acute myocardial failure, emergency cases, redo cases, malfunctioning artificial heart valve,obstructive cardiomyopathy, heart rate <50bpm, pericardial disease, renal impairment, hepatic impairment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to see the effect of magnesium sulfate infusion in reducing the blood sugar levls |
0 min, 10 min after induction, before cardiopulmonary bypass, 30 min afte CPB, ICU admsiion, 6 hours after ICU admission,12 hours after admission, 24 hours after admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| blood potassium levels, blood magnesium levels, total requirement of insulin hospital stay, hemodynamic chasnges, side effect of drug |
0 min, 10 min after induction, before cardiopulmonary bypass, 30 min afte CPB, ICU admsiion, 6 hours after ICU admission,12 hours after admission, 24 hours after admission |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/03/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
we wish to see the effect of magnesium sulfate infusion on blood sugar in patients with diabetes mellitus undergoing cardiac surgery . Magnesium plays a very important role in glycolysis, uptake of glucose in cells by increasing insulin sensitivity and insulin secretion from pancreas. It also helps in maintaining normal levels of potassium in blood in post cardiopulmonary state , thereby reducing arrythmias and mortality. Magnesium will be given intravenously at the rate of 15mg/kg/hr, and levels of magnesium , potassium and blood glucose levels will be checked at predetermined time intervals and will be compared with patients receiving normal saline instead of magnesium sulfate. |