| CTRI Number |
CTRI/2023/06/053435 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
01/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of intravenous Dexamethasone and intravenous Magnesium Sulphate during spinal anaesthesia. |
|
Scientific Title of Study
|
A COMPARATIVE STUDY EVALUATING THE EFFECT OF I.V MGSO4 AND I.V DEXAMETHASONE ON INTRAOPERATIVE HEMODYNAMICS AND POST OPERATIVE ANALGESIA AFTER SPINAL ANAESTHESIA IN LOWER LIMB SURGERIES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranay sah |
| Designation |
Post graduate student third year, MD anaesthesia |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and, mull |
| Address |
Room No. 18, Department of Anaesthesia, MMIMSR, MULLANA, AMBALA
Room No. 18, Department of Anaesthesia, MMIMSR, MULLANA, AMBALA
Ambala
HARYANA
133207
India |
| Phone |
8755088954 |
| Fax |
|
| Email |
Sahpranay75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ram Nandan Prasad |
| Designation |
Professor & Head |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and, mull |
| Address |
Room No. 01, Department of Anaesthesia, MMIMSR, Mullana, Ambala
Room No. 01, Department of Anaesthesia, MMIMSR, Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
8755088954 |
| Fax |
|
| Email |
drramnandanprasad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pranay sah |
| Designation |
Post graduate student third year, MD anaesthesia |
| Affiliation |
Maharishi Markandeshwar Institute of Medical Sciences and, mull |
| Address |
Room No. 18, Department of Anaesthesia , MMIMSR, MULLANA, AMBALA
Room No. 18, Department of Anaesthesia , MMIMSR, MULLANA, AMBALA
Ambala
HARYANA
133207
India |
| Phone |
8755088954 |
| Fax |
|
| Email |
Sahpranay75@gmail.com |
|
|
Source of Monetary or Material Support
|
| MMIMSR, MULLANA, Ambala, haryana, 133207 |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar Institute of Medical Sciences and Research Mullana |
| Address |
Maharishi Markandeshwar Institute of Medical Sciences and Research Mullana, Ambala |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pranay sah |
Maharishi markandeshwar institute of medical sciences and research |
Department of Anaesthesia, Old building, Operation theatre complex
Ambala
HARYANA |
8755088954
sahpranay75@gmil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE AFFILIATED TO MMIMSR |
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 |
intravenous Dexamethsone |
effect of Injection dexamethasone 8 mg in 100 ml normal saline intravenously before 15 mins of spinal anaesthesia on intraoperative hemodynamics and post operative analgesia after spinal anaesthesia. |
| Intervention |
intravenous magnesium sulphate |
effect of Injection magnesium sulphate 40mg/kg in 100 ml normal saline intravenously before 15 mins of spinal anaesthesia on intraoperative hemodynamics and post operative analgesia after spinal anaesthesia |
| Comparator Agent |
Iv dexamethasone Versus Iv magnesium sulphate |
Iv dexamethasone Versus Iv magnesium sulphate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2 patient undergoing elective lower limb surgeries under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
ASA 3 Aand ASA 4 PATIENT |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate intraoperative hemodynamics at baseline, 1min,3,5,10,30,60,90,120mins post spinal anaesthesia for post operative analgesia |
To quantify the post operative pain relief by verbal numeric rating scale at 1,3,6,12,24 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time elapsed till first demand for rescue analgesia and any side effects of the drug |
Till the end of surgery (approx 2 hr) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/06/2023 |
| 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="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this prospective randomised clinical trial is to evaluate the effect of IV magnesium sulphate and i.v. dexamethasone on intraoperative hemodynamics and post operative analgesia after spinal anaesthesia in lower limb surgeries |