| CTRI Number |
CTRI/2025/07/090895 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study of the Effect of Intratracheal and Intravenous Lignocaine on Airway and Hemodynamic responses during Emergence and Extubation in Laparoscopic Cholecystectomy under General Anesthesia. |
|
Scientific Title of Study
|
A Randomized Controlled Study of the Effect of Intratracheal and Intravenous Lignocaine on Airway and Hemodynamic responses in comparison with placebo Control during Emergence and Extubation in Laparoscopic Cholecystectomy under General Anesthesia at SMS Medical College, Jaipur |
| 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 Anupama Gupta |
| Designation |
Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesia SMS Medical College and Hospital Jaipur Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414240245 |
| Fax |
|
| Email |
anupamag213@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama Gupta |
| Designation |
Professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesia SMS Medical College and Hospital Jaipur Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414240245 |
| Fax |
|
| Email |
anupamag213@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajwal H L |
| Designation |
Resident Doctor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesia SMS Medical College and Hospital Jaipur Rajasthan 302004
Jaipur
RAJASTHAN
302004
India |
| Phone |
9844902874 |
| Fax |
|
| Email |
prajwal.mims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,SMS Medical College Jaipur |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Hospital |
| Address |
SMS Medical College and Hospital, JLN Marg,Jaipur Rajasthan 302004 |
| 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 Anupama Gupta |
SMS Medical College and Hospital |
Department of Anesthesiology SMS Medical College and Hospital, JLN Marg Jaipur Rajasthan 302004
Jaipur
RAJASTHAN |
94142 40245
anupamag213@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the ethics committee SMS Medical College and Attached Hospitals Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Nothing to be given before extubation |
| Intervention |
Intratracheal Lignocaine |
5 minutes before extubation , Intratracheal administration of 2% lignocaine at 3mg/kg dose. |
| Intervention |
Intravenous Lignocaine |
3 minutes before extubation, Intravenous administration of 2% lignocaine at 1.5 mg/kg dose. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing laparoscopic cholecystectomy under general anaesthesia.
2.Patients giving written and informed consent.
3.Patients age group between 18-70 years.
4.Patients with an American Society of Anaesthesiologist (ASA)class1,2&3.
|
|
| ExclusionCriteria |
| Details |
1.Patients with previous history of anaphylaxis/known allergy to lignocaine.
2.Patients with high risk of aspiration.
3.Patients with anticipated difficult airway.
4.Patients with history of chronic cough or bronchial asthma.
5.Patients with history of hypertension on beta blockers.
6.Patients with history of tracheal or laryngeal surgery.
7.Patient already a part of any other study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Proportion of cases of each cough reflex grade.
2.Mean of Heart rate , Systolic blood pressure, Diastolic blood pressure. |
Monitoring parameters at baseline , extubation, 1,2,3 and 5 minutes before and after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mean emergence time
2.Proportion of cases with adverse events |
Assessed at 5 minutes post extubation |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
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)
|
10/09/2025 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 is a prospective interventional double blind study to compare how Lignocaine and it’s different routes of administration influence the stability of the selected patients airway and hemodynamic status during critical period when patients regain consciousness and have breathing tube removed after surgery under general anaesthesia.This type of study is valuable for improving perioperative care and managing potential complications during the recovery phase after surgery. |