| CTRI Number |
CTRI/2024/02/063279 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
26/02/2024 |
| 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
|
Comparison between intravenous lignocaine and nebulization with lignocaine in suppressing response to laryngoscopy and intubation |
|
Scientific Title of Study
|
Lignocaine Nebulization versus Intravenous Lignocaine to suppress the hemodynamic response to Laryngoscopy and Tracheal Intubation: A Comparative Study |
| 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 Shipra Chandra |
| Designation |
Junior Resident 2 |
| Affiliation |
Government Medical College, Haldwani |
| Address |
Anaesthesia department 2nd floor Dr Susheela Tiwari hospital Government Medical College,Haldwani ,Nainital,Uttarakhand
Nainital
UTTARANCHAL
263139
India |
| Phone |
7830411262 |
| Fax |
|
| Email |
shiprachandra1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geeta Bhandari |
| Designation |
Proffessor and HOD, Dept of Anaesthesiology |
| Affiliation |
Government medical college Haldwani |
| Address |
Department of Anaesthesiology, Government Medical College Haldwani
Nainital
UTTARANCHAL
263139
India |
| Phone |
8650655556 |
| Fax |
|
| Email |
bhandari_geetantl@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geeta Bhandari |
| Designation |
Proffessor and HOD, Dept of Anaesthesiology |
| Affiliation |
Government medical college Haldwani |
| Address |
Department of Anaesthesiology, Government Medical College Haldwani
Nainital
UTTARANCHAL
263139
India |
| Phone |
8650655556 |
| Fax |
|
| Email |
bhandari_geetantl@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Shipra Chandra , Department of Anaesthesiology , Dr Susheela Tiwari Government Hospital , Haldwani , Uttarakhand ,263139 |
|
|
Primary Sponsor
|
| Name |
Dr Shipra Chnadra |
| Address |
Department of Anaesthesiology ,2nd floor Dr susheela Tiwari Government hospital Haldwani Uttarakhand |
| Type of Sponsor |
Other [Self] |
|
|
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 Shipra Chandra |
Dr. Susheela Tiwari Hospital |
Department of Anaesthesiology ,2nd floor , Rampur road ,Haldwani , Uttarakhand 263139
Nainital
UTTARANCHAL |
7830411262
shiprachandra1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GMC Haldwani |
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 |
Intravenous lignocaine and lignocaine nebulization |
It will be a double-blind clinical trial. The study participants and the researcher will be blinded of
the intervention that they will receive.
Group I –Nebulized with 2ml of 4% lignocaine(80mg) and 3 ml NS + 4 ml iv normal saline (NS)
will be given.
Group II - Nebulized with normal saline (NS) 5ml + 4ml IV 2% Xylocard (80mg) will be given.
Group III - Nebulized with normal saline (NS) 5ml + 4ml Normal saline (NS) IV will be given. Baseline parameters of the patient such as heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure and oxygen saturation will be recorded and Hemodynamic response to laryngoscopy and tracheal intubation such as Heart rate, Systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation will be noted for about 10-20 minutes after nebulization and intubation. |
| Intervention |
Intravenous lignocaine and nebulization with lignocaine |
It will be a double-blind clinical trial. The study participants and the researcher will be blinded of the intervention that they will receive. Group I –Nebulized with 2ml of 4% lignocaine(80mg) and 3 ml NS + 4 ml iv normal saline (NS) will be given. Group II - Nebulized with normal saline (NS) 5ml + 4ml IV 2% Xylocard (80mg) will be given. Group III - Nebulized with normal saline (NS) 5ml + 4ml Normal saline (NS) IV will be given.Baseline parameters of the patient such as heart rate, systolic blood pressure, diastolic blood pressure, mean arterial blood pressure and oxygen saturation will be recorded and Hemodynamic response to laryngoscopy and tracheal intubation such as heart rate , systolic blood pressure, diastolic blood pressure , mean arterial blood pressure and oxygen saturation will be noted for about 10-20 minutes after nebulization and intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. patient giving consent
2. all patients aged 18-45yrs
3. ASA grade 1&2
4. both genders
5.hemodynamically stable patients
6. patients undergoing elective surgical procedures under GA
7. patient not receiving any vasoactive drugs. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal for giving consent
2. Patient who already received lignocaine by any route.
3. Hypersensitivity to lignocaine.
4. History of convulsions.
5. Patient receiving vasoactive drug support.
6. Patient on mechanical ventilation with endotracheal or tracheostomy tube.
7. H/O COPD, cardiovascular disease, psychiatric disorders and liver disorders.
8. Patients with anticipated difficult airway.
9. Patients having history of laryngeal, tracheal surgery or any pathology. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the haemodynamic response during laryngoscopy and endotracheal intubation. |
20-30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the complication associated with nebulization vs intravenous lignocaine.
2.To evaluate the suppression of arrhythmia if any during laryngoscopy and intubation.
3. To compare the suppression of autonomic nervous system associated with nebulization vs
intravenous lignocaine. |
20 minutes |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
07/03/2024 |
| 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
|
The present study is a Prospective , Randomized and comparative study done after the approval of Institutional Ethics Committee in patients aged 18-45yrs of age satisfying all inclusion and exclusion criteria planned for elective surgery under GA. Materials used will be 4% lignocaine , 2% xylocard , nebulization mask , Anesthesia workstation , multipara monitor, suction apparatus , IV fluids , emergency drugs, Laryngoscope and Endotracheal tubes of various sizes.
The patients will be randomly allocated into 3 groups. Group 1 will be nebulized with 2ml of 4% lignocaine and 3ml of NS + 4ml IV normal saline will be given . Group 2 will be nebulized with normal saline 5ml + 4ml iv 2% xylocard will be given. Group 3 will be nebulized with NS 5ml + 4ml NS IV will be given. The parameters such as SBP, DBP, MAP, HR, and SPO2 will be recorded as baseline before starting nebulization at T0 and then every 5 minutes during nebulization . After 30 min of nebulization patient will be taken inside the operation theatre and all non invasive monitors will be attached. Airway will be secured with appropriately sized cuffed endotracheal tube and the parameters such as SBP, DBP, MAP, HR, Oxygen saturation will be recorded before laryngoscopy , immediately after intubation , 1 minute after intubation and every 5 minutes after intubation for 20 minutes.
Effect of nebulized versus intravenous lignocaine will be compared to suppress the hemodynamic response to laryngoscopy and tracheal intubation. |