| CTRI Number |
CTRI/2022/10/046496 [Registered on: 14/10/2022] Trial Registered Prospectively |
| Last Modified On: |
08/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To Compare which drug is better out of Injection Lignocaine , Esmolol And Magnesium Sulphate to Decrease the body’s stress response to Inserting a tube in trachea. |
|
Scientific Title of Study
|
A Comparative Study of Intravenous Lignocaine, Esmolol And Magnesium Sulphate For Attenuation Of Sympathoadrenal Response To Endotracheal Intubation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vishal Dahiya |
| Designation |
Resident Doctor (PG-1) |
| Affiliation |
ABVIMS and Dr. RML hospital |
| Address |
ABVIMS and Dr. RML hospital , New Delhi
ABVIMS and Dr. RML hospital , New Delhi-110001
New Delhi
DELHI
110001
India |
| Phone |
9205457280 |
| Fax |
|
| Email |
vdahiya32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalita Chaudhary |
| Designation |
Director Professor |
| Affiliation |
Department of Anaesthesia,ABVIMS and Dr. RML hospital, New Delhi |
| Address |
Department of Anaesthesia,ABVIMS and Dr. RML hospital , New Delhi
ABVIMS and Dr. RML hospital , New Delhi-110001
New Delhi
DELHI
110001
India |
| Phone |
9968299710 |
| Fax |
|
| Email |
lalitachaudhary055@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishal Dahiya |
| Designation |
Resident Doctor (PG-1) |
| Affiliation |
ABVIMS and Dr. RML hospital |
| Address |
ABVIMS and Dr. RML hospital , New Delhi
ABVIMS and Dr. RML hospital , New Delhi-110001
New Delhi
DELHI
110001
India |
| Phone |
9205457280 |
| Fax |
|
| Email |
vdahiya32@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology , ABVIMS and Dr. RML hospital, New Delhi-110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr RML Hospital |
| Address |
ABVIMS and Dr. RML Hospital , New Delhi -110001 |
| 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 |
| Dr Vishal Dahiya |
ABVIMS and Dr. RML Hospital, New Delhi |
Department of Anaesthesia, ABVIMS and Dr. RML Hospital , New Delhi-110001
New Delhi
DELHI |
9205457280
vdahiya32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , ABVIMS and Dr.RML Hospital, New Delhi-110001 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Attenuation of Sympathoadrenal Response to Endotracheal Intubation by Drugs |
patients are divided into 3 random groups. Only 1 drug will be given to 1 patient. Once the drug is chosen randomly following is the route, dosage and frequency of its administeration:Intravenous Lignocaine(1.5mg/kg), 1 minute before intubation as a single bolus dose.
Esmolol(1mg/kg),1 minute before intubation as a single bolus dose.
Magnesium Sulphate(30mg/kg), 10 minutes before intubation as infusion . |
| Comparator Agent |
Intravenous Lignocaine , Esmolol and Magnesium Sulphate |
Comparing Intravenous Lignocaine(1.5mg/kg) , Esmolol (1mg/kg)and Magnesium Sulphate (30mg/kg)for Attenuation of Sympathoadrenal Response to Endotracheal Intubation. These 3 drugs will be compared based on the hemodynamic parameters - Heart rate, Blood pressure (systolic and diastolic), Mean arterial pressure and biochemical markers - serum norepinephrine and blood glucose. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anaesthesiology(ASA) Physical status I and II.
2. Elective surgical procedure.
3. Either sex.
4. Consenting adults of age 18-55 years. |
|
| ExclusionCriteria |
| Details |
1. A known sensitivity to any study drug.
2. Pregnant females.
3. Patient with chronic Hypertension or Diabetes Mellitus.
4. Patient on beta- blocker.
5. Patient with history of cardiac or respiratory disease.
6. Patient with anticipated difficult airway.
7. Patient with impaired kidney or liver function. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hemodynamic response to Endotracheal Intubation (HR,SBP,DBP,MAP)
|
Pre-operative
1 minute after Endotracheal Intubation
3 minutes after Endotracheal Intubation
5 minutes after Endotracheal Intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Biochemical markers of stress response( Serum Norepinephrine and blood sugar) |
Baseline(at arrival in OT)
5min after Endotracheal Intubation |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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)
|
20/10/2022 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients posted for elective surgeries under General Anaesthesia will be assessed for Eligibility criteria. After informed consent , patient taken into OT. Intravenous access achieved , baseline hemodynamic parameters recorded and baseline blood sample for biochemical markers taken. Randomisation into 3 groups ( Group A- given Intravenous Lignocaine 1.5mg/kg) , (Group B - given Intravenous Esmolol 1mg/kg) , ( Group C- given Intravenous Magnesium sulphate 30mg/kg) . Induction of General Anaesthesia with Propofol 2 mg/kg and fentanyl 1.5 mcg/kg , followed by vecuronium bromide 0.1mg/kg for NM blockade. Following the Endotracheal Intubation , hemodynamic monitoring at 1min , 3min ,5 min and blood sampling at 5 min post intubation is done. Statistical analysis will be applied to the data collected and conclusion will be made . |