| CTRI Number |
CTRI/2021/09/036202 [Registered on: 03/09/2021] Trial Registered Prospectively |
| Last Modified On: |
01/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study among Intravenous Lignocaine, 2% Lignocaine Nebulisation and 4% Lignocaine Nebulisation in blunting of Laryngeal Response during Intubation, randomised clinical trial |
|
Scientific Title of Study
|
Effect of Lignocaine airway nebulisation vs intravenous lignocaine on intubation response in General anaesthesia patients. A Comparative Randomised clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravichandra Kumar Davuluri |
| Designation |
PG Resident |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
Pondicherry Institute of Medical Sciences,
Kalapet, Pondicherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9786287000 |
| Fax |
|
| Email |
vinay.ravichandra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramyavel T |
| Designation |
Associate Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Pondicherry Institute of Medical Sciences
Pondicherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9487630425 |
| Fax |
|
| Email |
ramyavel1988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramyavel T |
| Designation |
Associate Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Pondicherry Institute of Medical Sciences
Pondicherry
Mahe
PONDICHERRY
605014
India |
| Phone |
9487630425 |
| Fax |
|
| Email |
ramyavel1988@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical Sciences |
| Address |
Pondicherry Institute of Medical Sciences,
Pondicherry |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ravichandra Kumar Davuluri |
Pondicherry Institute of Medical Sciences |
Department of Anaesthesiology
Pondicherry Institute of Medical Sciences
Pondicherry
PONDICHERRY |
9786287000
vinay.ravichandra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS Institute Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine intravenous |
Group 1: Will receive 5 ml of 2% lignocaine nebulisation 10 min prior to induction and equivalent volume of normal saline IV 90 sec before intubation.
Group 2: Will receive 5 ml of 4% lignocaine nebulisation 10 min prior to induction and equivalent volume of normal saline iv 90 sec before intubation.
Group 3: Will receive 5 ml of normal saline nebulisation 10 min prior to induction and 1.5mg/kg of 2 % lignocaine iv 90 sec before intubation.
|
| Comparator Agent |
Lignocaine nebulisation |
Group 1: Will receive 5 ml of 2% lignocaine nebulisation 10 min prior to induction and equivalent volume of normal saline IV 90 sec before intubation. Group 2: Will receive 5 ml of 4% lignocaine nebulisation 10 min prior to induction and equivalent volume of normal saline iv 90 sec before intubation. Group 3: Will receive 5 ml of normal saline nebulisation 10 min prior to induction and 1.5mg/kg of 2 % lignocaine iv 90 sec before intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged between 18 and 60 yrs.
2)American Society of Anaesthesiologists ASA 1 and ASA 2 patients coming for GA.
3)Patients coming for elective procedures.
|
|
| ExclusionCriteria |
| Details |
1) Surgery involving the oral, nasopharyngeal, laryngotracheal airway or thyroid.
2) Patients history of respiratory disease (COPD, asthma).
3) History of recent respiratory tract infection.
4) Patients with anticipated difficult intubation and
Those requiring > 3 attempts at laryngoscopy and intubation.
5) History of any known allergy to Lignocaine.
6) Patients coming for emergency procedures.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective: To compare hemodynamic responses to Intubation in topical
2% lignocaine and 4% lignocaine patients and compare it with intravenous lignocaine
in patients undergoing General anaesthesia.
|
Baseline, 1min, 2min, 3min, 4min, 5min, 10min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study any adverse drug reactions |
1min, 2min, 3min, 4min, 5min, 10min |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
15/09/2021 |
| 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="3"
Months="0"
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
|
Effect of Lignocaine airway nebulisation vs intravenous lignocaine on intubation response in General Anaesthesia patients, a comparative randomised clinical trial. |