| CTRI Number |
CTRI/2024/10/074913 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparing usefulness of lignocaine and magnesium sulphate in reducing succinylcholine produced muscle twitching and postoperative body pain |
|
Scientific Title of Study
|
A comparative study of effect of intravenous magnesium sulphate versus lignocaine in reduction of succinylcholine induced fasciculations and postoperative myalgia in patients undergoing elective surgery |
| 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 Nidhishree V |
| Designation |
Postgraduate student |
| Affiliation |
ESIC Medical College PGIMSR |
| Address |
2nd floor OT complex, Department of Anesthesiology, ESIC medical college and PGIMSR Rajaji nagara, Banglore
Bangalore
KARNATAKA
560010
India |
| Phone |
99162337747 |
| Fax |
|
| Email |
nidhi975319@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G B Sumalatha |
| Designation |
Professor |
| Affiliation |
ESIC Medical College PGIMSR |
| Address |
2nd floor OT complex, Department of Anaesthesiology, ESIC medical college and PGIMSR Rajaji nagara, Banglore
Bangalore
KARNATAKA
560010
India |
| Phone |
9538301444 |
| Fax |
|
| Email |
gbsumaravi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NIDHISHREE V |
| Designation |
Postgraduate student |
| Affiliation |
ESIC Medical College PGIMSR |
| Address |
OT complex 2nd floor, Department of Anaesthesiology, ESIC medical college and PGIMSR Rajaji nagara, Banglore
Bangalore
KARNATAKA
560010
India |
| Phone |
9916237747 |
| Fax |
|
| Email |
nidhi975319@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College PGIMSR, Rajajinagar, Banglore, 560010 |
|
|
Primary Sponsor
|
| Name |
Dr NIDHISHREE V |
| Address |
ESIC Medical College PGIMSR, Rajajinagar, Banglore, Karnataka, 560010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Nidhishree V |
ESIC Medical College PGIMSR |
2nd floor OT complex , Department of Anaesthesiology, ESIC Meical College PGIMSR, Rajajinagar, Bangalore, 560010
Bangalore
KARNATAKA |
9916237747
nidhi975319@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESIC Institutional Ethics Committee |
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 |
Magnesium sulphate |
30mg/kg of Magnesium Sulphate in 10 ml isotonic 0.9%
saline slowly over ten minutes intravenously under monitoring before the induction
anesthesia.
|
| Comparator Agent |
preservative
free 2% lignocaine |
1.5mg/kg of Preservative free 2% lignocaine in 10
isotonic 0.9% saline over ten minutes intravenously before induction of anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anesthesiologists (ASA) physical status grade I and II
2.Modified Mallampati Airway (MMA) (Samsoon Young) class I And II
3. Scheduled for elective surgeries under general anesthesia.
4. Patient who are willing to give consent.Â
|
|
| ExclusionCriteria |
| Details |
1. Patients with history of significant systemic disorders (cardiovascular, respiratory, central nervous system or renal system)
2. Pre-existing musculoskeletal disorders.
3. Hypermagnesemia with a diagnosed condition or with altered serum values, altered liver function tests.
4.Beta-adrenergic or calcium channel blocker usage
5. Known hypersensitivity and contraindications to study drugs in allergic history family history. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To valuate the occurrence of succinylcholine induced fasciculation and post
operative myalgia after pre-treatment with IV Mgso4 30mg/kg and IV preservatives
free 2% lignocaine 1.5mg/kg |
From General anaesthesia induction to 24 hour postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the severity of succinylcholine induced fasciculation and postoperative
myalgia.
2. To compare the requirement of analgesics for postoperative myalgia for other than the
surgical site pain using Menckes Standardised Questionnaire |
From General anaesthesia induction to 24 hour postoperative period |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
20/10/2024 |
| 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="1"
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
|
This study is a Randomised , Comparative ,parallel group ,Double Blind Study to evaluate the occurrence of succinylcholine induced fasciculation and post operative myalgia after pre-treatment with IV Mgso4 30mg/kg and and IV preservatives free 2% lignocaine 1.5 mg/kg in total of 94 patients undergoing elective surgery . |