| CTRI Number |
CTRI/2024/12/077749 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Other (Specify) [Prospective double blind comparative study] |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study of two different doses of intravenous
Magnesium Sulphate in attenuation of stress response
in laryngoscopy and tracheal intubation |
|
Scientific Title of Study
|
A comparative study of two different doses of
Magnesium Sulphate in attenuation of stress response
in laryngoscopy and tracheal intubation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neelam Kumari Labana |
| Designation |
Resident doctor department of anesthesiology |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and research centre |
| Address |
Anesthesia department,Genaral ot complex,2nd floor,DHIRAJ Hospital,Smt Bhikiben Kanjibhai Shah Medical Instititute and Research Centre, Waghodiya ,Pipariya , Vadodara Waghodiya
Pipariya
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
08200847625 |
| Fax |
|
| Email |
neelam.labana22@gmail.com |
|
Details of Contact Person
Scientific 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 waghodiya
Pipariya,Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9879368363 |
| 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
Pipariya
Vadodara
GUJARAT
391760
India |
| Phone |
9879368363 |
| 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,Gujarat,India pin code-391760 |
|
|
Primary Sponsor
|
| Name |
Smt Bhikiben Kanjibhai Shah Medical Institute and research centre |
| Address |
waghodiya,pipariya, vadodara ,Gujarat ,India pin code-391760 |
| 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 |
| Dr 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 |
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: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intravenous MgSO4 30mg/kg |
Group I patients will be given intravenous MgSO4 30mg/kg i.v diluted in 50 ml normal saline infusion over 10 mins before induction of general anesthesia. |
| Comparator Agent |
intravenous MgSO4 50mg/kg |
Group II patients will be given intravenous MgSO4 50mg/kg i.v diluted in 50 ml normal saline infusion over 10 mins before induction of general anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients willing to participate in study
2)Patients willing to sign written & informed consent
3)Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II.
4)Patients posted for elective laparoscopy surgeries under general anesthesia
|
|
| ExclusionCriteria |
| Details |
1)Patient with ASA Grade III or IV
2)Serum Magnesium level more than 2.5mg/dl
3)Pregnant and lactating female
4)Patient with neuromuscular disorder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study hemodynamic and stress response in laryngoscopy and tracheal intubation |
preoperative
peri operative
At 1min
At 3min
At 5min
At 7min
At 10min
At 15min
At 30min
At 45min
At 60min
At 75min
At 90min
post operative:
1hr
2hr
4hr
6hr
12hr
24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of different doses of MgSO4 in attenuation of stress response |
Hemodynamic response will be compared in both the groups at premedication time, immediate post intubation, 5,10.30,60,120 min |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
This study is performed to compare the different doses of magnesium sulphate in attenuation of stress response in laryngoscopy and tracheal intubation . MgSO4 inhibits catecholamine release and acts on hemodynamic stability as a pre medication. It also have intraoperative as well as post operative analgesia through various mechanisms. Many individual studies are conducted for use of systemic MgSO4 indifferent doses .Very few studies are available on the effects of different doses of MgSO4 in attenuation of stress response during laryngoscopy and tracheal intubation. We are planning to conduct a study to compare the effect of different doses of MgSO4 in attenuation of stress response during laryngoscopy and tracheal intubation. |