| CTRI Number |
CTRI/2023/02/049799 [Registered on: 17/02/2023] Trial Registered Prospectively |
| Last Modified On: |
15/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
MAGNESIUM SULPHATE VS LIGNOCAINE INTRAVENOUS INFUSION FOR POSTOPERATIVE PAIN RELIEF |
|
Scientific Title of Study
|
A PROSPECTIVE, DOUBLE BLIND, RANDOMIZED CONTROLLED STUDY FOR
COMPARING THE EFFICACY OF PERIOPERATIVE I.V LIGNOCAINE VS I.V
MAGNESIUM SULFATE INFUSION IN ATTENUATING HEMODYNAMIC
PARAMETERS AND POSTOPERATIVE PAIN IN PATIENTS UNDERGOING
LAPAROSCOPIC HYSTERECTOMY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandakumar |
| Designation |
Post Graduate |
| Affiliation |
Tagore Medical College and Hospital |
| Address |
Department of Anaesthesia, Tagore Medical College and Hospital, Rathinamangalam, Chennai
Department of Anaesthesia, Tagore Medical College, Rathinamangalam, Chennai
Chennai
TAMIL NADU
600127
India |
| Phone |
9944584411 |
| Fax |
|
| Email |
nandachurchil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShankar Anand |
| Designation |
Associate Professor |
| Affiliation |
Tagore Medical College and Hospital |
| Address |
Department of Anaesthesia, Tagore Medical College and Hospital, Rathinamangalam
Kancheepuram
TAMIL NADU
600127
India |
| Phone |
9486476987 |
| Fax |
|
| Email |
drshankarmed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrShankar Anand |
| Designation |
Associate Professor |
| Affiliation |
Tagore Medical College and Hospital |
| Address |
Department of Anaesthesia, Tagore Medical College and Hospital, Rathinamangalam
Coimbatore
TAMIL NADU
600127
India |
| Phone |
9486476987 |
| Fax |
|
| Email |
drshankarmed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tagore Medical College and Hospital, Rathinamangalam, Chennai 600127 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Nandakumar |
Tagore Medical College |
Department of Anaesthesia, Tagore Medical College and Hospital
Kancheepuram
TAMIL NADU |
9944584411
nandachurchil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Tagore Medical College |
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 |
Lignocaine |
2% Lignocaine 1.5mg/kg over 10minutes followed by continous infusion of 1.5mg/kg in an iv line until the end of the surgery for 50 patients |
| Intervention |
Magnesium Sulphate |
Loading dose of 30mg/kg of magnesium sulfate followed by a maintanence dose of 15mg/kg/h continous infusion in an iv line until the end of the surgery for 50 patients |
| Comparator Agent |
Placebo (normal saline 0.9%) |
Normal saline, total volume of 20 ml before induction over a period of 15 min and maintenance 10 ml/h throughout the surgery via intravenous route for 50 patients |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing elective Laparoscopic Hysterectomy surgery under ASA-PS I&II |
|
| ExclusionCriteria |
| Details |
Patient who refused to give informed and written consent
Patients of ASA-PS III%IV
Patients who are allergic to Lignocaine or Magnesium sulfate
Patients on opioid medications
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain assesment by visual analog scale and opioid consumption by the patient in 1st 24Hours of the Post operative period |
Immediately after extubation,then Hourly in the first 24Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) will be continuously monitored and recoreded |
pre-op (baseline), pre-induction, post-induction and 1, 3, 5, 10 & 15 minutes after intubation and until the end of the surgery |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/02/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 aim of the study is to examine the effect of perioperative intravenous infusion of 2% Lignocaine vs Magnesium sulfate on Postoperative pain and opioid consumption, Hemodynamic parameters attenuation during pneumoperitoneum in patients undergoing Laparoscopic Hysterectomy. |