| CTRI Number |
CTRI/2020/07/026637 [Registered on: 17/07/2020] Trial Registered Prospectively |
| Last Modified On: |
03/07/2020 |
| 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
|
A clinical study to compare the effects of two drugs Lignocaine and Magnesium sulfate for cardiovascular response to Laryngoscopy and endotracheal intubation. |
|
Scientific Title of Study
|
Attenuation of cardiovascular response to laryngoscopy and endotracheal intubation: comparative evaluation of IV magnesium sulfate (20mg/kg) Vs IV lignocaine (1.5mg/kg) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARAVANAN V K |
| Designation |
POST GRADUATE |
| Affiliation |
BJMC AHMEDABAD |
| Address |
DEPARTMENT OF ANAESTHESIA,F3 BLOCK, CIVIL HOSPITAL, BJMC, AHMEDABAD
Ahmadabad
GUJARAT
380016
India |
| Phone |
7708009226 |
| Fax |
|
| Email |
saarvananvks1327@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MONAL RAMANI |
| Designation |
Associate Professor |
| Affiliation |
BJMC AHMEDABAD |
| Address |
Department of Anaesthesia, F3 block, civil campus, BJMC, Ahmedabad.
Ahmadabad
GUJARAT
380016
India |
| Phone |
9824758295 |
| Fax |
|
| Email |
monalramani@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
SARAVANAN V K |
| Designation |
POST GRADUATE |
| Affiliation |
BJMC AHMEDABAD |
| Address |
Department of Anaesthesia, F3 block, civil campus, BJMC Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
7708009226 |
| Fax |
|
| Email |
saarvananvks1327@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Civil campus, BJMC, Ahmedabad. |
|
|
Primary Sponsor
|
| Name |
MEDICAL COLLEGE SUPPLY |
| Address |
BJMC AHMEDABAD |
| Type of Sponsor |
Government 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 |
| SARAVANAN VK |
MAJOR OT, NEUROSURGERY OT, ORTHOPEDIC OT, UROSURGERY OT |
BJMC AHMEDABAD
Ahmadabad
GUJARAT |
7708009226
saarvananvks1327@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITTEE, BJMC, AHMEDABAD |
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 |
| Comparator Agent |
iv LIGNOCAINE 1.5mg/kg |
ATTENUATION OF CARDIOVASCULAR RESPONSE TO LARYNGOSCOPY AND INTUBATION
Dose 1.5 mg/kg
Drug given intravenously as a premedication 20 minutes before giving general anaesthesia to the patient. |
| Intervention |
iv MgSo4 20mg/kg |
ATTENUATION OF CARDIOVASCULAR RESPONSE TO LARYNGOSCOPY AND INTUBATION
Dose 20 mg/kg
Drug given intravenously as premedication 20 minutes before giving general anaesthesia to the patient |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT REQUIRING GENERAL ANEAESTHESIA UNDER ASA GRADING I AND II |
|
| ExclusionCriteria |
| Details |
KNOWN HYPERTENSIVES
POOR LEFT VENTRICULAR FUNCTION
EMERGENCY SURGERY
DIABETICS
DIFFICULT AIRWAY
IMPAIRED RENAL FUNCTION AND ELECTROLYTE IMBALANCE |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Attention of cardiovascular responses such as Heart rate and Blood pressure after Laryngoscopy and tracheal intubation.
|
First five minutes after Laryngoscopy and tracheal intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic stability at the start of the surgery. |
Fifteen minutes after induction of general anaesthesia. |
|
|
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)
|
02/08/2020 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
Laryngoscopy and tracheal intubation violate the patients protective airway reflexes and lead to adverse hemodynamic and cardiovascular responses. several agents have been tried to obtund the pressor response. Recently, the role of magnesium has been evaluated for different purposes for anaesthetic and Intensive care units. We have undertaken this study to assess the efficacy of intravenous Magnesium sulphate as premedication in attenuating the pressor responses to laryngoscopy and tracheal intubation. |