| CTRI Number |
CTRI/2024/12/077689 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study of Intravenous Lignocaine vs Magnesium Sulphate as Pre-medications in Laparoscopic Surgery: Impact on Pain Relief, Blood Pressure, and Recovery |
|
Scientific Title of Study
|
An observational comparative study of intravenous Lignocaine
versus intravenous Magnesium Sulphate as a Pre medication in
laparoscopic surgery under General Anesthesia for –
Perioperative analgesia , Hemodynamic stability and
post operative recovery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neelamkumari Labana |
| Designation |
Resident doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anesthesia Department,General ot complex,2nd floor,Dhiraj hospital,smt. bhikiben kanjibhai shah medical institute and research centre,Waghodiya,pipariya,Vdodara
Vadodara
GUJARAT
391760
India |
| Phone |
08200847625 |
| Fax |
|
| Email |
neelam.labana22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jatin Patel |
| Designation |
Professor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anesthesia department, General OT complex,2st floor, Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and research centre, Waghodiya ,Pipariya, ,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
09879368363 |
| Fax |
|
| Email |
dr_jatinpatel@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jatin Patel |
| Designation |
Professor in Department of Anesthesiology |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and research centre |
| Address |
Anesthesia department, General OT complex,2nd floor, Dhiraj Hospital, Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre,Waghodiya,Pipariya,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
09879368363 |
| Fax |
|
| Email |
dr_jatinpatel@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Smt.Bhikiben Kanjibhai Shah Medical Institute and research centre, aghodiya, pipariya , vadodara |
|
|
Primary Sponsor
|
| Name |
Smt.Bhikiben Kanjibhai Shah Medical Institute and research centre |
| Address |
waghodiya,pipariya, vadodara |
| 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 |
| Neelam Labana |
Smt.Bhikiben Kanjibhai Shah Medical Institute and research centre |
Anesthesia department, General OT complex, Dhiraj Hospital, SBKS MIRC, waghodiya, pipariya, vadodara
Vadodara
GUJARAT
Vadodara
GUJARAT |
08200847625
neelam.labana22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDHYAPEETH INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj magnesium sulphate intravenous 30 mg/kg infusion |
inj magnesium sulphate 30mg/kg intravenous infusion 10 minutes before induction |
| Intervention |
Intravenous infusion of Lignocaine 1.5mg/kg
Intravenous infusion |
Intravenous infusion of Lignocaine 1.5 mg/kg 10 minutes before induction
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to sign written & informed consent.
• Patients belonging to American Society of Anesthesiologists (ASA) physical
status I and II.
• Patients posted for elective laproscopy surgeries under general anesthesia |
|
| ExclusionCriteria |
| Details |
Patient with ASA Grade III or IV
Serum Magnesium level more than 2.5mg/dl
Pregnant and lactating female
Patient with neruomuscular disorder
Patient with psychiatry disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare efficacy of systemic Lignocaine
versus Magnesium Sulphate as a Pre medication in
laparoscopic surgery under General Anaesthesia for –
Perioperative analgesia , Hemodynamic stability. |
Baseline
after induction
1 mim
3min
5min
7min
15 min
30 min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare efficacy of systemic Lignocaine
versus Magnesium Sulphate as a Pre medication in
laparoscopic surgery under General Anaesthesia for –
post operative recovery and analgesia |
Measurement of VAS score and Hemodynamic parameter at
Immediate Post opertaive
30 mins
1 hr
2 hr
6 hr
12 hr
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/12/2024 |
| 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="6"
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
|
The purpose of this study is to compare efficacy of systemic Lignocaine versus Magnesium Sulphate as a Pre medication in laparoscopic surgery under General Anaesthesia for – Perioperative analgesia , Hemodynamic stability and post operative recovery. |