| CTRI Number |
CTRI/2025/09/094904 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Magnesium sulphate and its help in reducing the postoperative pain and ileus |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED TRIAL TO STUDY THE EFFECT OF PREOPERATIVE SYSTEMIC
MAGNESIUMSULFATE INFUSION ON POST OPERATIVE PAIN AND POST OPERATIVE ILEUS
FOLLOWING NON LAPAROSCOPIC MAJOR ABDOMINAL SURGERIES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VUPPARAPALLI SIVA RAM VARMA |
| Designation |
MS General Surgery Post Graduate |
| Affiliation |
Chettinad Hospital And Research Institute |
| Address |
A block,Department of General Surgery, Chettinad hospital and Research Institute, Chettinad health city, SH 49A, Kelambakkam, Tamilnadu, 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
8978136040 |
| Fax |
|
| Email |
vsivaram19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Muthu Raj |
| Designation |
Professor of General Surgery |
| Affiliation |
Chettinad hospital and research institute |
| Address |
A block,Department of General Surgery, Chettinad hospital and Research Institute, Chettinad health city, SH 49A, Kelambakkam, Tamilnadu, 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7305705536 |
| Fax |
|
| Email |
drmuthurajkasinathan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Muthu Raj |
| Designation |
Professor of General Surgery |
| Affiliation |
Chettinad hospital and research institute |
| Address |
A block,Department of General Surgery, Chettinad hospital and Research Institute, Chettinad health city, SH 49A, Kelambakkam, Tamilnadu, 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
7305705536 |
| Fax |
|
| Email |
drmuthurajkasinathan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad hospital and research institute, Chettinad health city, Rajiv gandhi salai, kelambakkam, Chennai, Tamilnadu, 603103 |
|
|
Primary Sponsor
|
| Name |
Chettinad Hospital and Research Institute |
| Address |
Chettinad hospital and research Institute, Chettinad health city, SH 49A, Kelambakkam, Tamilnadu, 603103 |
| Type of Sponsor |
Private 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 Vupparapalli Siva Ram Varma |
Chettinad hospital and research institute |
Department of General Surgery, A Block, Chettinad hospital and research Institute, Chettinad health city, SH 49A, Kelambakkam, Tamilnadu, 603103
Kancheepuram
TAMIL NADU |
8978136040
vsivaram19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional human ethics committee (CARE IHEC-I) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MagnesiumSulphate |
40mg/kg magnesium sulfate in
100ml ns 30 minutes before induction as IV infusion |
| Comparator Agent |
normal saline |
normal saline infusion given preoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age more than 18 and less than 60 years.
Patients undergoing open abdominal surgeries.
Patients who received ASA 1, 2 in Pre anaesthetic check.
Patients with normal Serum Magnesium levels.
Patients who consented to be included in the study |
|
| ExclusionCriteria |
| Details |
Patients of age less than 18 and more than 60 years.
Patients with Liver failure, Renal failure, Heart block, Arrythmia, EF less than 45 percent, Pregnancy,
Neurological disorders, Hypersensitivity
Patients with serum magnesium above normal.
Patients with Blood glucose more than 200mg/dl on the day of surgery.
Patient on Calcium channel blockers.
Patients undergoing laparoscopic abdominal surgeries
Those who don not give consent to be included in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the reduction of duration of post operative ileus on Mgso4 infusion |
1, 2, 4, 12, 24 hrs post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the reduction of post operative pain on Mgso4 infusion |
1, 2, 4, 12, 24 hours post operatively |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/09/2025 |
| 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
|
Post operative pain management and control may help in early mobilisation and recovery of the patient. Pain during surgery is managed intraoperatively by General anaesthesia or spinal anaesthesia or regional anaesthesia. Post operative pain is managed either by Epidural top up or by IV/IM analgesics. Magnesium is the 4th most common cation in the body and is called the nature’s physiological calcium channel blocker. It interferes with calcium channels and NMDA receptors play an important role in pain relief. Activation of NMDA cause calcium and sodium influx into cell and with an e lux of potassium and initiation of central sensitization of pain. NMDA receptor antagonist plays an important role in central sensation of pain by preventing it. NMDA receptor signalling may be important factor determining the duration and intensity of postoperative pain. Hypomagnesemia is one of the known causes of Ileus. There have been several studies that investigate the e ect of pre and intra op magnesium sulphate infusion and its role in reducing post op analgesia required, where as there is a lack of studies investigating its e ect on post operative ileus. METHODOLOGY: Study design – Prospective Randomised Control trail Sample size-50 Sampling technique- lottery technique SUBJECT SELECTION: INCLUSIVE CRITERIA: This is a RCT study in department of general surgery, Chettinad health and research institute, Kelambakkam, Tamilnadu in patients undergoing major abdominal surgeries.Patients of age >18 and <60 years. Patients undergoing open abdominal surgeries.Patients who received ASA 1, 2 in Pre anaesthetic check.Patients with normal Serum Magnesium levels. Patients who consented to be included in the study. EXCLUSIVE CRITERIA: Patients of age <18 and >60 years. Patients with Liver failure, Renal failure, Heart block, Arrythmia, EF<45%, Pregnancy, Neurological disorders, Hypersensitivity Patients with serum magnesium above normal. Patients with Blood glucose >200mg/dl on the day of surgery. Patient on Calcium channel blockers. Patients undergoing laparoscopic abdominal surgeries Those who don’t give consent to be included in the study. STUDY PROCEDURE: All the patients who fit the inclusion criteria will be observed and following data will be collected 1. Routine blood investigations 2. Pre operative serum magnesium levels 3. Comparative study done , Study group will receive 40mg/kg magnesium sulfate in 100ml ns 30 minutes before induction as IV infusion and using equal volume of Normal saline in control group Postoperative pain on 1st, 2nd ,4th , 12th , 24th postoperative hour as per visual analogue pain scale. Postoperative Time of 1st appearance of bowel sounds noted. Postoperative Time of 1st passage of flatus noted. STATISTICAL METHODS: All collected data will be evaluated using appropriate statistical method SOURCES OF FUNDING AND FINANCIAL REQUIREMENTS FOR THE PROPOSAL: Expenses related to pre- operative, intra-operative and post-operative phase shall be met by the patient. For economically weaker section of patients, a request for concession shall be referred to hospital’s MS o ice with relevant documents (Below poverty line card, Aadhar card) to get permissible and applicable concessional treatment. ETHICAL ISSUES INVOLVED AND MEASURES TO BE TAKEN TO PREVENT ETHICAL ISSUES: Approval of CHRI ethical committee will be obtained. All participants will be informed regarding the purpose of study, pros and cons of the infusio, complication associated with the procedure and confidentiality of research study in local language. An informed consent will also be taken from the study participants who are willing to participate in the study. Consent also shall be taken to reproduce his or her investigations, films clinical evaluation data for publishing in index journals without compromising his or her confidentiality. REFERENCE: Bathina AV, Peetani RK, Vaitla VT. A prospective randomized controlled trial to study the e ect of preoperative and intraoperative magnesium over postoperative ileus and postoperative pain in major non–laparoscopic abdominal surgeries. International Surgery Journal. 2019 Aug 28;6(9):3182-7 |