| CTRI Number |
CTRI/2025/02/080043 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| 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
|
Effect of Magnesium Sulphate on depth of Anaesthesia, awareness incidence and pain relief after abdominal surgery |
|
Scientific Title of Study
|
Effect of Magnesium Sulphate on depth of Anaesthesia, awareness incidence and pain relief after abdominal surgery-a parallel group, single blind,prospective randomised 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 |
RAJ BHUSAN PRASAD |
| Designation |
Post Graduate trainee |
| Affiliation |
Institute Of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital |
| Address |
Institute Of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
Bhawanipore,
Kolkata
Institute Of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
Bhawanipore,
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9679625885 |
| Fax |
|
| Email |
rajbhusanprasad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. SURAJIT CHATTOPADHYAY |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Institute Of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital |
| Address |
Department of Anaesthesia,
Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital,
Bhawanipore,
Kolkata
Department of Anaesthesia,
Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital,
Bhawanipore,
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
8100765206 |
| Fax |
|
| Email |
surajit.chattopadhyay270@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAJ BHUSAN PRASAD |
| Designation |
Post Graduate trainee |
| Affiliation |
Institute Of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital |
| Address |
Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital,
Bhawanipore,
Kolkata
Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital,
Bhawanipore,
Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9679625885 |
| Fax |
|
| Email |
rajbhusanprasad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology, Institute of Post graduate Medical Education and Research,
AJC Bose road, Kolkata 700020 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital |
| 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 Raj bhusan Prasad |
Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital |
Main block,Main Operation theatre,OT1 and OT 2
Bhowanipore,
Kolkata,
West Bengal 700020
Kolkata
WEST BENGAL |
9679625885
rajbhusanprasad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
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 |
Intraoperative magnesium sulphate |
Intraoperative magnesium sulphate mixed with normal saline infusion for 90 minutes
Total duration of study 18 months |
| Comparator Agent |
Normal saline infusion |
Normal saline infusion,placebo
Total duration of study 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing Abdominal surgery |
|
| ExclusionCriteria |
| Details |
-Patient with hypermagnesaemia -Patient with any heart block -Patient with hypertension -Patient with diabetes mellitus -Patient with pre-term pregnancy, multiple pregnancies -Patient’s refusal |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| bispectral index |
Baseline,5 minutes then every 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)To access the effect of magnesium sulphate on pain relief as well as incidence of awareness after abdominal surgery. 2)To evaluate the total analgesic consumption during first post-operative day. 3)To observe the time for first rescue analgesia. 4)To study haemodynamic variables( Pulse rate,Mean arterial pressure) 5)To study drug side effects if any. |
Baseline,5 minutes then every 15 minutes,post operative day 1 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
17/02/2025 |
| 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="6"
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
|
A total of 100 patients of ASA I and II,18-60 years of age of either sex undergoing abdominal surgery under general anaesthesia will be randomly allocated into two equal groups.BIS monitor will be attached to assess depth of anaesthesia, and data will be collected before induction(BIS 0),at five minutes (BIS 5),then every 15 minutes.Group S will receive 20ml 0.9% Normal saline(NS) over 15-20 seconds and 500ml 0.9% NS at 15ml/kg/hour. Group SM will receive 20ml 0.9% NS with Magnesium sulphate 40mg/kg over 15-20 seconds and 500ml 0.9% NS with Magnesium sulphate at 15mg/kg/hour. |