| CTRI Number |
CTRI/2023/10/058197 [Registered on: 03/10/2023] Trial Registered Prospectively |
| Last Modified On: |
03/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of xylocaine on intraocular pressure during intubation |
|
Scientific Title of Study
|
A prospective placebo controlled study to evaluate the effect of intravenous 2% xylocaine on intraocular pressure (IOP) during endotracheal intubation in non ophthalmic surgeries |
| 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 Shubham Bhardwaj |
| Designation |
PG (1st year ) student MD |
| Affiliation |
Maharaja agrasen medical College agroha hisar |
| Address |
Room no 114 OP jindal boys hostel MAMC agroha hisar
Hisar
HARYANA
125047
India |
| Phone |
09416699782 |
| Fax |
|
| Email |
bhardwaj09shubham@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Kumar |
| Designation |
Professor |
| Affiliation |
Maharaja agrasen medical College agroha hisar |
| Address |
MAMC agroha hisar
Hisar
HARYANA
125047
India |
| Phone |
8059598861 |
| Fax |
|
| Email |
docsanjeevparmar77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Bhardwaj |
| Designation |
PG (1st year ) student MD |
| Affiliation |
Maharaja agrasen medical College agroha hisar |
| Address |
Room no 114 OP jindal boys hostel MAMC agroha hisar
Hisar
HARYANA
125047
India |
| Phone |
09416699782 |
| Fax |
|
| Email |
bhardwaj09shubham@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology and critical care
Maharaja agrasen medical College agroha hisar |
|
|
Primary Sponsor
|
| Name |
Department of anesthesiology and critical care |
| Address |
Maharaja agrasen medical College agroha hisar |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Parveen Kumar |
Maharaja agrasen medical College agroha hisar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shubham Bhardwaj |
Maharaja agrasen medical College agroha hisar |
Department of anesthesiology and critical care
Hisar
HARYANA |
09416699782
bhardwaj09shubham@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for human research maharaja agrasen medical College agroha hisar |
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 |
2% Xylocaine |
2% Xylocaine in dose of 2mg per kg BW (diluted upto 6 ml) injected intravenously ( duration of study around 20 minutes) |
| Comparator Agent |
Normal saline |
6ml normal saline intravenously ( duration of study around 20 minutes) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Belong to ASA class I and II
2.Weight ranging from 45-60 kg
3.Non-ophthalmic surgeries |
|
| ExclusionCriteria |
| Details |
1. Anticipated difficult airway
2.history of hypertension
3. Treatment with beta blockers and calcium channel blockers or any other drug causing hemodynamic instability
4. Laryngoscopy time more than 30 seconds
5. Allergic to Xylocaine
5.pregnant and lactating mothers
6. Patients refusal to participate in study
7. Ophthalmic surgeries
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the changes on intraocular pressure (IOP) after giving 2% intravenous xylocaine. |
Intraocular pressure (IOP) will be measured by Perkins tonometer at pre induction baseline immediately after intubation & 1 3 5 & 15 minutes after that |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the hemodynamic changes due to 2% intravenous xylocaine during endotracheal intubation. |
Heart rate today Systolic blood pressure, Diastolic blood pressure & Mean Blood Pressure ) will be measured by monitoring at pre induction (baseline), immediately after intubation and 1,3,5 and 15 minutes after that. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/10/2023 |
| 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="6" |
|
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
|
Tracheal intubation is a time tested method to achieve the airway control in anaesthesia practice and resuscitation. Tracheal intubation is one the important techniques during anaesthesia to secure patient airway. However, tracheal intubation and extubation during anaesthesia may be associated with significant risks. Airway control with tracheal intubation during general anaesthesia can be associated with increasing in Intraocular pressure (IOP) due to an increase in blood pressure and blood flow to the eye1.However, there is paucity of information on how does xylocaine blunt the intraocular pressure (IOP) responses during intubation. This study was designed to find the effect of intravenous xylocaine on intraocular pressure(IOP) responses during intubation. |