| CTRI Number |
CTRI/2024/11/076902 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Pain-Relieving Effects of IV Paracetamol vs. IV Magnesium Sulfate During General Anesthesia in Patients Undergoing Major Abdominal and Upper Limb Surgeries |
|
Scientific Title of Study
|
A Comparative Study of the Analgesic Effects of Intravenous Paracetamol and Intravenous Magnesium Sulfate Under General Anesthesia in Patients Undergoing Major Abdominal and Upper Limb 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 RAJ BAHADUR SINGH |
| Designation |
Associate Professor |
| Affiliation |
IGIMS,Patna |
| Address |
Department Of Anaesthesiology[ Trauma and Emergency]
Indira Gandhi Institute Of Medical Sciences,Sheikhpura,Patna,Bihar,India
Department Of Anaesthesiology[ Trauma and Emergency]
Indira Gandhi Institute Of Medical Sciences,Sheikhpura,Patna,Bihar,India
Patna
BIHAR
800014
India |
| Phone |
07897844636 |
| Fax |
|
| Email |
virgodocraj36@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJ BAHADUR SINGH |
| Designation |
Associate Professor |
| Affiliation |
IGIMS,Patna |
| Address |
Department Of Anaesthesiology[ Trauma and Emergency]
Indira Gandhi Institute Of Medical Sciences,Sheikhpura,Patna,Bihar,India
Department Of Anaesthesiology[ Trauma and Emergency]
Indira Gandhi Institute Of Medical Sciences,Sheikhpura,Patna,Bihar,India
Patna
BIHAR
800014
India |
| Phone |
07897844636 |
| Fax |
|
| Email |
virgodocraj36@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR RAJ BAHADUR SINGH |
| Designation |
Associate Professor |
| Affiliation |
IGIMS,Patna |
| Address |
Department Of Anaesthesiology[ Trauma and Emergency]
Indira Gandhi Institute Of Medical Sciences,Sheikhpura,Patna,Bihar,India
Department Of Anaesthesiology[ Trauma and Emergency]
Indira Gandhi Institute Of Medical Sciences,Sheikhpura,Patna,Bihar,India
Patna
BIHAR
800014
India |
| Phone |
07897844636 |
| Fax |
|
| Email |
virgodocraj36@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology[ Trauma and Emergency]
Indira Gandhi Institute Of Medical Sciences,Sheikhpura,Patna,Bihar,India,800014 |
|
|
Primary Sponsor
|
| Name |
IGIMSPATNA |
| Address |
Department Of Anaesthesiology[ Trauma and Emergency]
Indira Gandhi Institute Of Medical Sciences,Sheikhpura,Patna,Bihar,India,800014 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| IGIMS PATNA |
Department Of Anaesthesiology[ Trauma and Emergency]
Indira Gandhi Institute Of Medical Sciences,Sheikhpura,Patna,Bihar,India,800014 |
|
|
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 Bahadur Singh |
Indira Gandhi Institute Of Medical Sciences |
Department Of Anaesthesiology[ Trauma and Emergency]
Indira Gandhi Institute Of Medical Sciences,Sheikhpura,Patna,Bihar,India,800014
Patna
BIHAR |
07897844636
virgodocraj36@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IGIMS,PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (3) ICD-10 Condition: K36||Other appendicitis, (4) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (5) ICD-10 Condition: K420||Umbilical hernia with obstruction,without gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intravenous drugs given for preemptive analgesia |
after induction and intubation of patient under General Anaesthesia ,Paracetamol 20 mg/kg iv over 10 min as infusion. |
| Comparator Agent |
INTRAVENOUS MAGNESIUM SULPHATE |
after induction and intubation of patient under General Anaesthesia , Magnesium sulphate 20 mg /kg in 100 ml NS over 10 min immediately after intubation before starting of surgery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient scheduled for lower abdominal and lower limb surgeries under General anaesthesia.
2.Patient in ASA grade I and II.
3.Age between 18 - 65 years.
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal for General anesthesia.
2.Patient refusal to enroll for the study.
3.Patients with cardiovascular disease, renal failure, hepatic dysfunction and chronic pulmonary disease.
4.Obesity (BMI ≥ 30)
5.Bleeding disorders
6.History of allergy or sensitivity to any of the study drug |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The role of intra operative Magnesium sulphate infusion as perioperative analgesic
2.To compare the efficacy of Magnesium sulphate infusion with infusion of Paracetamol in the quality and duration of postoperative analgesia in patients undergoing major surgeries under GA
3.Hemodynamic changes intra-operative
4.Side effects ,if any
|
1.The role of intra operative Magnesium sulphate infusion as perioperative analgesic
2.To compare the efficacy of Magnesium sulphate infusion with infusion of Paracetamol in the quality and duration of postoperative analgesia in patients undergoing major surgeries under GA
3.Hemodynamic changes intra-operative
4.Side effects ,if any
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
decrease in VAS score
Side Effects if any |
till 24 hours post surgery |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [virgodocraj36@yahoo.co.in].
- For how long will this data be available start date provided 03-11-2024 and end date provided 03-11-2025?
Response (Others) - nil
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
RESEARCH QUESTION Does magnesium sulphate gives better analgesic effect than paracetamol postoperatively. AIMS To compare the efficacy of intra-operative I.V. Magnesium sulphate versus I.V. Paracetamol on post operative analgesic requirement in major surgeries under general anaesthesia. OBJECTIVES To compare the following Parameters:- 1. The role of intra operative Magnesium sulphate infusion as perioperative analgesic 2.To compare the efficacy of Magnesium sulphate infusion with infusion of Paracetamol in the quality and duration of postoperative analgesia in patients undergoing major surgeries under GA 3.Hemodynamic changes intra-operative 4.Side effects ,if any |