| CTRI Number |
CTRI/2025/09/095467 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of intravenous magnesium and vitamin C in reducing severity of pain in the immediate postoperative period |
|
Scientific Title of Study
|
Efficacy of intraoperative magnesium and vitamin C in the reduction of severity of pain in immediate postoperative period |
| 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 Rajmala Jaiswal |
| Designation |
Senior Professor |
| Affiliation |
Pt BD Sharma University of Health Sciences Rohtak |
| Address |
Department of Anesthesiology and Critical Care PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8222897449 |
| Fax |
|
| Email |
Para3007@rediff.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Aggarwal |
| Designation |
Senior Resident |
| Affiliation |
Pt BD Sharma University of Health Sciences Rohtak |
| Address |
Department of Anesthesiology and Critical Care PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
08607920759 |
| Fax |
|
| Email |
aggarwal.priyanka93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajmala Jaiswal |
| Designation |
Senior Professor |
| Affiliation |
Pt BD Sharma University of Health Sciences Rohtak |
| Address |
Department of Anesthesiology and Critical Care PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8222897449 |
| Fax |
|
| Email |
Para3007@rediff.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care PGIMS Rohtak Haryana India 124001 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care PGIMS Rohtak , Haryana ,India,124001 |
| Address |
Department of Anesthesiology and Critical Care PGIMS Rohtak |
| 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 Priyanka Aggarwal |
Pt BD Sharma University of Health Sciences PGIMS Rohtak |
Department of Anesthesiology and Critical Care PGIMS Rohtak
Rohtak
HARYANA |
08607920759
aggarwal.priyanka93@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pt BD Sharma University of Health Sciences PGIMS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M899||Disorder of bone, unspecified, (2) ICD-10 Condition: M974||Periprosthetic fracture around internal prosthetic elbow joint, (3) ICD-10 Condition: M979||Periprosthetic fracture around unspecified internal prosthetic joint, (4) ICD-10 Condition: M668||Spontaneous rupture of other tendons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous magnesium and intravenous vitamin C |
Post intubation 3 grams of intravenous vitamin C in 100 ml NS and 2 grams of intravenous magnesium sulphate in 100 ml NS over 30 minutes |
| Comparator Agent |
Intravenous normal saline |
100 ml of normal saline will be given post intubation over 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients on agr group 18 to 60 years of either sex belonging to ASA I and II will be included in study who will undergo upper limb orthopedic surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Unwillingness of patient to participate in study, history of chronic pain, opioid or analgesic abuse, Cardiovascular disease, respiratory, neuromuscular, renal and hepatic disease, anaemia, dyselectrolytemia and massive blood loss, major oncosurgeries, duration of surgery more than 3 hours, pregnant and lactating women, previous history of allergy to study drug |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of postoperative pain as measured on VAS scale (0-10) in immediate postoperative period at 0 hour (in recovery room) followed by at every 10 minutes over the next 3 hours |
Severity of postoperative pain as measured on VAS scale (0-10) in immediate postoperative period at 0 hour (in recovery room )followed by at every 10 minutes over the next 3 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to request for first dose of rescue analgesia(I.V Tramadol 1 mg/kg) over 3 hours in recovery room
Time interval after administration of study drug to time to request for 1st dose of rescue analgesia.
Total dose of analgesia after 1st requirement with a lock out interval of 10 minutes (I.V Tramadol 0.25 mg/kg with maximum dose of 1 mg/kg) over next 3 hours
|
Time to request for first dose of rescue analgesia(I.V Tramadol 1 mg/kg) over 3 hours in recovery room
Time interval after administration of study drug to time to request for 1st dose of rescue analgesia.
Total dose of analgesia after 1st requirement with a lock out interval of 10 minutes (I.V Tramadol 0.25 mg/kg with maximum dose of 1 mg/kg) over next 3 hours
|
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
24/10/2025 |
| 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="1"
Days="1" |
|
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
|
All patients will be subjected to the pre-anaesthetic assessment prior to enrollment in the study. Their detailed medical and surgical history will be taken along with any previous anaesthetic exposure with its outcome. A thorough airway, systemic examination will also be done. All patients scheduled for surgery will be kept fasting for at least 6 hours prior to surgery. Randomization will be done by using computer generated numbers into three groups; Group 1 study group (n=30)- patients receiving intravenous vitamin C 3 grams in 100 ml NS, Group II study group (n=30)- patients receiving intravenous magnesium sulphate 2 grams in 100 ml NS, Group III control group (n=30) - patients receiving normal saline. The study drug will be prepared and administered by anaesthesia resident who is not further involved in study. After extubation, postoperative pain will be assessed using VAS scale (0-10) by anaesthesia resident who is involved in the study. Other observations includes time to request for 1st dose of rescue analgesia (i.v Tramadol 1mg/kg) followed by 0.25 mg/kg every 10 minutes over next 3 hours to reduce VAS to 4, time interval between administration of study drug to time to request for first dose of rescue analgesia, total dose of Tramadol, side effects. |