| CTRI Number |
CTRI/2025/03/082280 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparitive study of effect of intravenous magnesium sulphate versus epidural magnesium sulphate in patients undergoing gynecological oncologic surgeries |
|
Scientific Title of Study
|
A prospective comparative study of effect of intravenous magnesium sulphate versus epidural magnesium sulphate on postoperative pain in patients undergoing laparoscopic gynecological oncologic 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 |
Dr.Amrutha Arnepalli |
| Designation |
Post graduate resident |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Kidwai memorial institute of oncology, Room no 105, Operation theatre complex ,Department of Anesthesiology and Pain Relief, Dr M H Marigowda road ,Bangalore
560029
Bangalore
KARNATAKA
560029
India |
| Phone |
8341295050 |
| Fax |
|
| Email |
amrutha2807@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RASHMI N R |
| Designation |
Associate Professor |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Kidwai Memorial Institute of Oncology, Room no 105, Operation theatre complex ,Department of Anesthesiology and Pain Relief, Dr M H Marigowda road ,Bangalore
560029
Bangalore
KARNATAKA
560029
India |
| Phone |
8792406774 |
| Fax |
|
| Email |
drrashmisatheesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RASHMI N R |
| Designation |
Associate Professor |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Kidwai Memorial Institute of Oncology, Room no 105, Operation theatre complex ,Department of Anesthesiology and Pain Relief, Dr M H Marigowda road ,Bangalore
560029
Bangalore
KARNATAKA
560029
India |
| Phone |
8792406774 |
| Fax |
|
| Email |
drrashmisatheesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kidwai Memorial Institute of Oncology, Room no 105, Operation theatre complex ,Department of Anesthesiology and Pain Relief, Dr M H Marigowda road ,Bangalore
560029 |
|
|
Primary Sponsor
|
| Name |
Dr Amrutha Arnepalli |
| Address |
Room number 9 ,Post graduate women hostel, kidwai memorial institute of oncology , Hombegowda nagar, Bengaluru ,Karnataka (state)- 560029 |
| Type of Sponsor |
Other [SELF] |
|
|
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 AMRUTHA ARNEPALLI |
Kidwai memorial institute of oncology |
Room no 105, Operation theatre complex ,Department of Anesthesiology and Pain Relief, Dr M H Marigowda road Bangalore
560029
Bangalore
KARNATAKA |
8341295050
amrutha2807@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MEDICAL ETHICS COMMITTEE, KIDWAI MEMORIAL INSTITUTE OF ONCOLOGY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary, (2) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Epidural Magnesium sulphate |
Epidural Bolus of 10ml of diluted Magnesium sulphate 50mg/kg prior to induction followed by 20mg/kg infusion epidurally after creation of pneumoperitoneum |
| Comparator Agent |
Intravenous Magnesium sulphate |
Intravenous Bolus of Magnesium sulphate 50mg/kg body weight prior to induction followed by 20mg/kg infusion after creation of pneumoperitoneum |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients consenting for study
2. Patients having normal range of Serum magnesium levels.
3. ASA I and II patients
4. Female patients aged between 18-65 years |
|
| ExclusionCriteria |
| Details |
1. Patients who refuse epidural anaesthesia
2. Patients allergic to magnesium sulphate
3. Patients with known neuro muscular diseases, atrio ventricular conduction disturbances
4. Patients receiving treatment with calcium channel blockers or magnesium. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare post operative pain using Visual Analogue Scale in both the study groups. |
24 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compare requirement of post operative rescue analgesia, intra operative muscle relaxants, intra operative haemodynamic parameters in both the study groups |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
31/03/2025 |
| 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="2"
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
|
This is a prospective comparitive study of effect of intravenous magnesium sulphate over epidural magnesium sulphate in patients undergoing laparoscopic gynaecological oncological surgeries. Intravenous magnesium sulphate could be used as an alternativeto epidural as it requires less equipment , less cost and less tedious process. Group A patients will receive bolus of 10ml of 50mg/kg diluted form of intravenous magnesium sulphate prior to induction and will be started on 20mg/kg/hr magnesium sulphate intravenous infusion at the start of pneumoperitoneum. Group B will recieve bolus of 10 ml of 50mg/kg diluted form of magnesium sulphate epidurally and will be started on infusion of 20mg/kg/hr magnesium sulphate epidurally at the start of pneumoperitoneum and these infusions shall be continued till the end of surgery. Intraoperative haemodynamic parameters like heart rate, systolic and diastolic blood pressure, saturation, end tidal carbon dioxide levels, and first requirement of muscle relaxant will be recorded at the baseline,at time of study drug, intervals of 5min, 10min,15min, 30min intervals till end of procedure. Post operative pain scale using VAS score, requirement of rescue analgesic will be recorded immediatly after intubation, 30 min after intubation, hourly intervals till first 6 hours, 2hourly till 12hrs post procedure, and 24th hourly.
|