| CTRI Number |
CTRI/2024/03/064679 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, lignocaine and esmolol for decreasing optic nerve sheath diameter in patients undergoing laryngoscopy and endotracheal intubation |
|
Scientific Title of Study
|
COMPARISON OF INTRAVENOUS LIGNOCAINE WITH ESMOLOL FOR ATTENUATING INCREASE IN OPTIC NERVE SHEATH DIAMETER DURING LARYNGOSCOPY AND ENDOTRACHEAL 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 |
Priyanka Godara |
| Designation |
PG Anaesthesia |
| Affiliation |
VMMC & Safdarjung Hospital, New Delhi |
| Address |
Department Of Anaesthesia, Main OT building, Room number 1, Division 1, Ground floor, Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9873784755 |
| Fax |
|
| Email |
priyankagodara3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonali Banwait |
| Designation |
Associate Professor |
| Affiliation |
VMMC & Safdarjung Hospital, New Delhi |
| Address |
Department Of Anaesthesia, Main OT building, Room number 1, Division 1, Ground floor, Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9811783404 |
| Fax |
|
| Email |
sonalibanwait@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Banwait |
| Designation |
Associate Professor |
| Affiliation |
VMMC & Safdarjung Hospital, New Delhi |
| Address |
Department Of Anaesthesia, Main OT building, Room number 1, Division 1, Ground floor,Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi
South
DELHI
110029
India |
| Phone |
9811783404 |
| Fax |
|
| Email |
sonalibanwait@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
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 Priyanka Godara |
Vardhman mahavir medical College and safdarjung hospital, New Delhi-110029 |
Room no. 1, Division 1, Ground floor, Department of anaesthesia, Main OT building
South
DELHI |
9873784755
priyankagodara3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H470||Disorders of optic nerve, not elsewhere classified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intravenous lignocaine and esmolol |
Intravenous lignocaine 1.5 mg/kg and esmolol 0.5 mg/kg, 180 seconds before laryngoscopy and endotracheal intubation |
| Intervention |
Intravenous lignocaine and esmolol |
Intravenous lignocaine 1.5 mg/kg and esmolol 0.5 mg/kg, 180 seconds before laryngoscopy and endotracheal intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patients with psychiatric illness/ any space occupying lesion in CNS, on beta blockers, known eye disease, difficult airway, allergic to lignocaine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Optic nerve sheath diameter using ocular ultrasonography |
Optic nerve sheath diameter before, at after 5, 10, 15 minutes of laryngoscopy and endotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate and blood pressure values |
Throughout the procedure after every 10 minutes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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 Yet Recruiting |
| 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 Prospective Randomized, Comparative study done in department of anaesthesia, VMMC & SJH to compare intravenous lignocaine with esmolol for attenuating optic nerve sheath diameter during laryngoscopy and endotracheal intubation. The optic nerve sheath diameter is measured by ocular ultrasonography before, during and after 5, 10, 15 minutes of laryngoscopy and endotracheal intubation. Along with optic nerve sheath diameter measurement, Blood pressure and heart rate is also monitored thorough-out the procedure. |