| CTRI Number |
CTRI/2022/03/040821 [Registered on: 04/03/2022] Trial Registered Prospectively |
| Last Modified On: |
24/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of giving lignocaine by intravenous or nebulization to reduce the pressor responses during endotracheal intubation and laryngoscopy. |
|
Scientific Title of Study
|
Comparison of efficacy of nebulized lignocaine with intravenous lignocaine for attenuation of pressor response to laryngoscopy and intubation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K T Sreekanth Balagopal |
| Designation |
Postgraduate resident in Anaesthesiology |
| Affiliation |
B.J medical college and Civil hospital ,Ahmedabad |
| Address |
F3,1st floor, department of anaesthesia, B.J medical college, Civil hospital,Asarwa, Ahmedabad-380016 Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
7975936468 |
| Fax |
|
| Email |
sbkonnnath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Professor |
| Affiliation |
B.J medical College, Civil Hospital, Ahmedabad |
| Address |
F3,1st floor, department of anaesthesia, B.J medical college, Civil hospital,Asarwa, Ahmedabad-380016 Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Professor |
| Affiliation |
B.J medical College, Civil Hospital, Ahmedabad |
| Address |
F3,1st floor, department of anaesthesia, B.J medical college, Civil hospital,Asarwa, Ahmedabad-380016 Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
|
Source of Monetary or Material Support
|
| BJ medical college,Civil hospital,Government of Gujarat |
|
|
Primary Sponsor
|
| Name |
Government of Gujarat |
| Address |
7th floor, Health and family welfare department, Sachivalay ,Gandhinagar |
| 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 K T Sreekanth Balagopal |
General Surgery operation theatres |
Major surgery Operation theatre, General surgery department, 5th floor, Trauma building, Civil hospital, Ahmedabad, Gujarat
Ahmadabad
GUJARAT |
7975936468
sbkonnanath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, B.J medical college and Civil hospital, 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 |
| Intervention |
Intravenous 1.5mg/kg lignocaine bolus and nebulized lignocaine-2% for 20 minutes. |
Comparison of efficacy of nebulized lignocaine 2% for 20minutes with intravenous lignocaine 1.5mg/kg bolus for attenuation of pressor response to laryngoscopy and intubation. |
| Comparator Agent |
Lignocaine by either intravenous 1.5mg/kg bolius or 2% by nebulization route for 20 minutes. |
Comparison of efficacy of 2% nebulized lignocaine for 20 minutes with intravenous lignocaine 1.5mg/kg bolus for attenuation of pressor response to laryngoscopy and intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
63.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients posted for surgery under general anaesthesia requiring endotracheal intubation.
|
|
| ExclusionCriteria |
| Details |
Patients with pre existing hypertension, Patients with known allergy to the study drug or contraindication to any of the administered drugs, Patients with anticipated difficult airway, Patients who refused or inability to understand the procedure.
5. Patients who are smokers
6. Patients with History of respiratory distress
7. Patients with gastroesophageal reflux,Neurological ,cardiovascular,respiratory ,hepatic or renal dise
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of efficacy of the NL as compared to IVL in suppressing pressor response to laryngoscopy and intubation
|
Starting of nebulized lignocaine/Intravenous lignocaine to 20th minute after endotracheal intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluation of efficacy of the 2% lignocaine nebulization for 20minutes as compared to 1.5mg/kg intravenous lignocaine bolus in
suppression of arrhythmias/any other complications if any during laryngoscopy and intubation.
|
Preoperatively before induction starting of 2% nebulized lignocaine/1.5mg/kg Intravenous lignocaine upto 20 minutes after endotracheal intubation. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/03/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
After completion of study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Despite adequate anaesthetic depth, direct laryngoscopy and intubation elicit
a significant adreno-sympathetic response. This response, as manifested by
increased blood pressure (BP), heart rate (HR), arrythmias etc. Lignocaine given
intravenous or topically (nebulization) attenuates pressor responses to
laryngoscopy and intubation. Very few studies lignocaine by nebulization has
been done to evaluate the effect on pressor responses. The present study was undertaken to compare the efficacy of intravenous
lignocaine 2%versus efficacy of nebulized lignocaine before induction of
anaesthesia in attenuating the pressor response to direct laryngoscopy and
endotracheal intubation.
|